Total 1,026 Others product specialist job vacancies in Quality Assurance / Control category in Singapore

Functions:

1. To manage the regulatory compliance function of the company, which include medical device registration, post market surveillance, clinical evaluation.
2. To ensure compliance with regulatory requirements from countries / regions such as the EU (MDR), US (FDA), Malaysia (MDA) and so on.
3. To develop and maintain Technical Documentation for each medical device category.
4. To participate in developing and maintaining Standard Operating Procedures, Work Instructions and Specifications that comply with the relevant regulatory and customer requirements.
5. To keep abreast of the regulatory changes and its implications, keeping management apprised at all times.

Profile:

1. Degree / diploma in medical, engineering, science or regulatory field
2. A minimum of 2 years' experience in regulatory affairs in the medical device industry
3. Practical experience in dealing with regulatory bodies (Malaysia MDA or foreign authorized representative such as the EU)
4. Good organization skills and proactive in ensuring regulatory requirement are met.
5. Good communication skills to maintain communication with external and internal stakeholders.
6. Good written skills in English.
7. Auditing experience in ISO 13485 or GDPMD will be and added advantage.

Perks & Benefits

• Medical insurance
• Personal leave

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Why Join Us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us!

Job Summary

Plan, co-ordinate and oversee all QA support activities and initiatives in the work cell. To improve process capabilities and product quality to meet the desired targets.

Job Description

• Oversee the product quality from assembly to packaging process and ensure full compliance to the Quality System and regulation requirements.
• Champion data-driven decisions to resolve non-conformances, complaint investigation, CAPA, deviation and other quality matters in a timely manner.
• Interfaces with R&D, unit quality, customer quality engineer to formulate plans and actions to meet product specifications and quality requirements
• Drive quality improvement/automation projects through project planning, scheduling inspection/testing activities, performing analysis and publishing reports.
• Perform test method validation, installation qualification, correlation study for new quality equipment/test method.
• Act as a support role for regulatory, external, internal and/or supplier audits and lead the value stream members to execute the corrective actions for compliance with customer specifications.
• Perform data analysis and trending for product quality performance through monthly and quarterly management review meeting.
• Establish and maintain effective system and procedures to ensure that all manufacturing and engineering documentation are controlled and updated per established regulatory requirements.
• Supervise quality technical specialist and a group of technicians on quality tests and checks.
• Safety & ISO 14001 Environmental accountability: Ensure a safe, healthy and environmentally-friendly workplace by observing Company's rules and procedures. Active involvement in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement and reduction of resource materials.
• Perform any other tasks as assigned.

Preferred Requirements

• Minimum 3 to 5 years relevant working experiences in a quality engineer role.
• Demonstrated good understanding of key elements of Quality Management system, CFR Part 820, ISO 13485.
• Have prior experience in managing quality improvement projects would be an added advantage
• Able to effectively multi-task and work independently with a high level of initiative

Click on apply if this sounds like you!

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

To learn more about BD visit: https://bd.com/careers

Primary Work Location

SGP Tuas - Tuas Plant

Position subject to a 5-day minimum on-site work requirement per 10-day pay period.

Applicants should apply to the location(s) they are able to regularly report to. Location will be determined once selection(s) is made. Salary posted reflects pay range for all locations. Once the selection has been made, the salary will be set in accordance with the selectee's location.

The positions can be filled in any of the following locations:

• Chicago, IL: $80,994 - 126,198
• Columbus, OH: $75,646 - $117,866
• Detroit, MI: $80,006 - $124,659
• Indianapolis, IN: $73,218 - $114,082
• Kansas City, MO $73,690 - $114,818
• Milwaukee, WI: $75,864 - $118,205
• Minneapolis, MN: $78,969 - $123,043
• Omaha, NE: $73,249 - $114,131
• St. Louis, MO: $74,299 - $115,766

• Assists in planning, developing, and implementing the region's outreach program.
• Represents the region at contractor meetings, seminars, and workshops.
• Identifies and maintains working relationships with public and private stakeholders (federal contractors, industry liaison groups, trade/industry associations, chamber of commerce, educational institutions, and others) to promote equal employment opportunity and the concept of voluntary compliance with Office of Federal Contract Compliance Programs (OFCCP) Equal Employment Opportunity (EEO) regulations.
• Promotes voluntary compliance; keeps the public aware of changes in the equal employment opportunity rules and requirements regarding E.O. 11246, Section 503, the Americans with Disabilities Act, and VEVRAA; makes public presentations; serves on panels in seminars, conferences, and EEO compliance meetings.
• Conducts public demonstrations of OFCCP computer-based and/or Internet outreach materials to further public knowledge and use of materials interpreting equal employment opportunity standards and regulations. Coordinates outreach efforts for and works with first-time contractors.
• Fosters creative partnerships with federal contractors, linkage organizations and other federal contracting agencies, industry liaison groups, trade associations, and others interested in equal employment opportunity.
• Participates in compliance evaluations and complaint investigations.
• Develops strategies for investigation or data collection and analysis, conciliates issues, negotiates with officials, and may use precedents to draft remedies for discriminatory practices and other noncompliance designed to correct the violation(s).

Position subject to a 5-day minimum on-site work requirement per 10-day pay period.

Applicants should apply to the location(s) they are able to regularly report to. Location will be determined once selection(s) is made. Salary posted reflects pay range for all locations. Once the selection has been made, the salary will be set in accordance with the selectee's location.

The positions can be filled in any of the following locations:

• Chicago, IL: $80,994 - 126,198
• Columbus, OH: $75,646 - $117,866
• Detroit, MI: $80,006 - $124,659
• Indianapolis, IN: $73,218 - $114,082
• Kansas City, MO $73,690 - $114,818
• Milwaukee, WI: $75,864 - $118,205
• Minneapolis, MN: $78,969 - $123,043
• Omaha, NE: $73,249 - $114,131
• St. Louis, MO: $74,299 - $115,766

• Assists in planning, developing, and implementing the region's outreach program.
• Represents the region at contractor meetings, seminars, and workshops.
• Identifies and maintains working relationships with public and private stakeholders (federal contractors, industry liaison groups, trade/industry associations, chamber of commerce, educational institutions, and others) to promote equal employment opportunity and the concept of voluntary compliance with Office of Federal Contract Compliance Programs (OFCCP) Equal Employment Opportunity (EEO) regulations.
• Promotes voluntary compliance; keeps the public aware of changes in the equal employment opportunity rules and requirements regarding E.O. 11246, Section 503, the Americans with Disabilities Act, and VEVRAA; makes public presentations; serves on panels in seminars, conferences, and EEO compliance meetings.
• Conducts public demonstrations of OFCCP computer-based and/or Internet outreach materials to further public knowledge and use of materials interpreting equal employment opportunity standards and regulations. Coordinates outreach efforts for and works with first-time contractors.
• Fosters creative partnerships with federal contractors, linkage organizations and other federal contracting agencies, industry liaison groups, trade associations, and others interested in equal employment opportunity.
• Participates in compliance evaluations and complaint investigations.
• Develops strategies for investigation or data collection and analysis, conciliates issues, negotiates with officials, and may use precedents to draft remedies for discriminatory practices and other noncompliance designed to correct the violation(s).

Administered by the Workforce Advancement Federation (WAF), the Career Conversion Programme (CCP) for Biomedical Manufacturing Executives is a premier talent development initiative designed to cultivate the next generation of skilled professionals for Singapore’s Biomedical manufacturing industry. This comprehensive 15-month programme features structured on-the-job training (OJT) provided at Novartis Singapore Pharmaceutical Manufacturing Pte Ltd (NSPM), facilitating the practical application of acquired knowledge and ensuring participants develop the essential competencies required for their roles.

Eligilibity for CCP:

• Singapore Citizen or Permanent Resident;

• Minimum 21 years old;

• Mid-Career Individual: Graduated, or completed National Service, whichever is later, for at least 2 years* prior at the point of application; or

• Fresh Graduate: Graduated, or completed National Service, whichever is later;

• Not in a similar job function prior to joining Career Conversion Programme (CCP);

• Have not attended the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously;

• Have not been funded under the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously.

• Should not be shareholders, immediate ex-employees of Novartis, or be related to shareholders of Novartis.

Successful candidates must be able to commence the program by March 2025.

Job Purpose

Responsible for providing quality oversight to ensure smooth manufacturing operation and new product launches/transfer in a compliant and timely manner. Support drug substance batch review and release in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objective/s.

Key Responsibilities

Operational

a. Provide Quality oversight to site operations/objectives

· Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance.

· Participate/Support meetings (as required) and team tiered process to monitor/detect/act on anomalies to key site quality KPIs and continuous improvement.

b. Review/ Release of Raw materials and manufactured materials

· Perform and be responsible in ensuring Batch record review and/or release (raw materials and manufactured materials – for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards

· Support the release team in batch release in ensuring batch release (manufactured materials – for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards.

c. Support exception investigations and change control activities

· Lead/support in ensuring a smooth manufacturing operations in production/QC/Logistics, in handling deviations/capa, change control, complaints, customer management, escalation, recall etc are in full cGMP compliance to regulatory and Novartis Quality Standards

d. Support OpEx improvement projects

· Support for end-to-end lifecycle management, timely review & escalation, stakeholder management to achieve agreed outcomes for projects assigned and areas under responsibility

e. New Product Introduction

· Support in ensuring success to new product launch/transfer and equipment/product lifecycle management are in full cGMP compliance to regulatory and Novartis Quality Standards e.g., Product Transfer, Equipment Qualification, Computerized System Validation, Shipping Validation, Cleaning Validation, , Process Validation, Ongoing Process Verification & etc

f. Customer Management

· Lead/support network/project governance meeting and team tiered process to monitor/detect/act on anomalies to project milestones, KPIs and continuous improvement.

· Support in preparing customers request documentation or requests

g. Documents review

· Provide support (Review/Approval) of GMP Record/Document in ensuring compliance to regulatory and Novartis Quality Standards

h. Inspections

· Provide support in ensuring inspection readiness. Support customer, internal Novartis and Health Authority audits.

i. Any other task/duties assigned by Line Manager

Requirements

· University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

· Several years of experience in pharmaceutical quality control, quality assurance or production or relevant quality experience. Fresh graduates are welcome to apply.

· Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice

· New entrants to biopharmaceutical industry and should not be holding a bond obligation with any organisation

Job Brief:

Responsible for department management work.

Job Responsibilities:

• Responsible for standardization and improvement of department work flow. 
• Proper management of department fixed asset.
• Prepare daily/weekly and monthly reports and documents.
• Responsible for effective budget control.
• Responsible for basic education training and internal training for department new and existing staffs.
• Control and monitor for effective submaterial and general items purchase, usage and distribution.
• Responsible to ensure effective implementation of QMS, EMS, OSHAS, ISMS and RBA.
• Responsible for create / review quality related work flows.          
• To carry out/ conduct department process audit.            
• Ensure proper control on documentation of training records and inspectors' qualification.
• Responsible for internal QMS implementation and improvement activity.        
• To maintain effective communication with respective departments regarding QMS, consumable management and budget control.
• Ensure work area clean and tidy and adhere to company's 5S policy.         
• Plan and control for manpower headcount management.           
• Any other duties assigned by superior.              
• Plan and maintain calibration and overall jig/tool/equipment management.
• Plan and promote for department motivational activity.
• Monitoring of design change control.              
• Responsible for quality compliance implementation and improvement activity.       
• Control and manage for human and environment's safety and efficiency (OS &H).       
• Improve department 5S management.              

Job Requirements:

• Qualification : Candidate must possess at least degree in electrical/ mechanical or equivalent
• Experience : Preferably with more than 2 years experience in manufacturing environment especially in the field of quality control
• Skill : Good communication skills. Highly motivated and able to work independently
• Language : Good verbal and communication skill in English and added advantage if can converse in Japanese

• You will monitor the Contractor's Production, Quality and Manufacturing performance in the shipbuilding.
• You will monitor assignments to include: Procedures Evaluation, Product Verification and verification of contractor's records.
• You will performs inspection, sampling inspection, and witnesses functional tests of ship's equipment and systems.
• You will verify contractor conformance to applicable safety regulations.
• You will provide input to the contractor and SUPSHIP corrective action programs by initiating corrective Action Requests (CARS) and follows up to determine corrective action adequacy.
• You will function as a member of simulated INSURV Board during Builder's Trials and assists INSURV Board during Acceptance Trials.
• You will be required to work or assist in other offices of the Quality Assurance Department or Project Office as the workload dictates.
• You will review docking plans and inspects drydocks prior to docking and/or undocking of naval vessels by contractors under the cognizance of SUPS HIP Gulf Coast.
• You will will assist higher level Quality Assurance Specialists in the performance of Quality Assurance studies and analyses of limited scope and inspect relatively simple processes or products for developmental purposes.
• You will be Planning - Developing, implementing and coordinating activity and department quality functions.
• You will conducting audits - Preparation and implementation of audit plans and schedules for Contractor's and activity evaluation to determine degree of conformance.
• You will be training - Participates in training programs for QA Department and other concerned SUPSHIP Departments and Military (Nucleus Crew) personnel.

• Participates in Technical Evaluation Proposals (TEP) and Technical Panels (TP) for the DLA Troop Support Prime Vendor Program.
• Responsible for providing technical expertise for the interpretation of confidential documentation to Contracting officers, during the acquisition phase.
• Evaluates and approves Food Defense Plans (FD) for all subsistence contracts submitted with Technical Proposals/Bids.
• Evaluates and approves Quality Assurance Plans (QSP) for higher-level contracts
• Conducts QSMVs (CQAS, SPV, or PQA) to verify compliance for DoD contracts. Conducts QSMVs to individual audit sites which fall under the Audit Program
• Responsible for providing data collection processes, applying statistical analysis and developing recommendations for management decisions to improve product quality.
• Evaluates audit results to identify specification inadequacies and performance levels of audit sites to detect trends in non-conformance and to assess overall contract performance.

• Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data.
• Serves as a member of a multi-functional or technical team. Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more supplier’s facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractor’s quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

• Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data.
• Serves as a member of a multi-functional or technical team. Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more supplier’s facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractor’s quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

• Respond promptly and professionally to high-priority complaints or concerns escalated by internal departments or external stakeholders, ensuring a service-oriented approach.
• Act as a key point of contact between internal departments and external entities (e.g., citizens, businesses, and other government agencies) to resolve issues efficiently and effectively, with a commitment to delivering high-quality service.
• Ensure that all written communications adhere to relevant laws, regulations, and agency policies, while reflecting the agency’s commitment to quality service.
• Maintain detailed and organized records of escalations, including actions taken, outcomes, and follow-up requirements, to ensure accountability and continuous improvement in service delivery.
• Identify trends and recurring issues in escalated cases, and provide feedback to improve processes, policies, and communication strategies that enhance the quality of service. Prepare concise and insightful written briefs on complex escalated issues, offering recommendations that prioritize both resolution and service quality.

Requirement:

• Bachelor’s degree in Communications or similar related field.
• At least 2-3-years of experience in a writing or communications role
• Demonstrated ability to manage escalations and sensitive situations with tact and professionalism.
• Exceptional written and verbal communication skills.
• Ability to manage multiple tasks and work under pressure to meet deadlines.
• Experience in dispute resolution or customer service
• Analytical skills to assess complex issues and recommend solutions.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

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