Total 899 Quality Assurance / Control job vacancies in Atlantic City, New Jersey

• Contribute senior leadership and participates in regional business processes such as strategic planning, workload sharing, and quality management for engineering and construction.
• Serve as Division senior technical advisor to the districts in their discipline on engineering activities, responsible for the competence of projects designed and built in the Division.
• Provide leadership for solutions of advanced, unprecedented engineering problems to key managers, counterparts at the districts, higher headquarters, Corps research and development laboratories, and other Corps, government, and private interests.
• Participate in Regional and national-level meetings, workshops, committees, professional conferences, inter-agency panels, and boards for exchange of technical information and advice on matters regarding engineering.

About HOYA Surgical Optics (HSO)

HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.

HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.

At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.

HSO way of working

In fulfilling our roles, we are

• Accountable for our own capabilities and development,
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who

• See beyond themselves and are impact-focused,
• Consider the needs, challenges, and objectives of every person with whom they interact, and
• Exhibit positive reinforcement to help others succeed.

About the role

Works closely with and have impact on: Global Quality Assurance Team

Reports to: Senior QA Engineer

Function: Global QA

Work Location/Site: Singapore / GHQ

Internship Duration: Any 3 months between January to May 2025

Role Overview

The QA intern will support the quality and various project teams with validation needs in MasterControl, our cloud-based Quality Management System (QMS) for HSO.

Duties and Responsibilities

• Assist to perform validation duties to ensure software validation project and corresponding deliverables adhere to current regulations and quality standards
• Actively contribute towards continuous improvement of the quality team by suggesting new ideas and promoting innovative culture through improving and optimizing analysis of quality data and process workflows
• Provide support to record management and archiving activities
• Support post-migration and improvement activity works for the QMS
• Assist with QMS Modules improvement and maintenance activities
• Participate in team activities and initiatives related to QMS and regulatory requirements
• Other duties as assigned

Requirements

Experience

• N/A

Skills/Accreditations

• Microsoft office skills essential. Candidates with Excel Macro skills preferred
• Some Quality system knowledge will be advantageous
• Self-awareness and Good work ethics
• Strong communication and interpersonal skill

Academic Qualifications

• Pursuing Diploma or Degree Preferably in Science or Engineering

Travel requirements

• N/A

By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes.

We regret to inform you that due to the number of applications received, only shortlisted applicants will be notified. Thank you for your kind understanding.

About HOYA Surgical Optics (HSO)

HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.

HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.

At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.

HSO way of working

In fulfilling our roles, we are

• Accountable for our own capabilities and development,
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.
• We are looking for people who
• See beyond themselves and are impact-focused,
• Consider the needs, challenges, and objectives of every person with whom they interact, and
• Exhibit positive reinforcement to help others succeed.

About the role

Works closely with and have impact on: Global Research & Development (R&D), Post Market Surveillance, and Global Regulatory Affairs (RA) Teams

Reports to: Senior Manager QA R&D

Function: Global QA & Compliance Organization

Work Location/Site: Singapore / Global Headquarters

Role Overview

This position is responsible to ensure that products meet quality goals and regulatory requirements, including but not limited to FDA Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971 and maintain compliance of the Quality Management System (QMS).

Duties and Responsibilities

• Partner with R&D teams in the USA, Japan, and Singapore to ensure that design control is completed in accordance with procedures, WI, regulatory requirements, and assure that required outputs have been completed
• Execute risk management for devices, processes, and provide the assessment results from product development through to the launch
• Maintain and update risk management files with Global R&D/Manufacturing Engineering (ME) teams to support product development (Risk Management Plans, Risk Control Log, Benefit Risk Assessment Risk Management Report, xFMEA, etc.), and act as the Risk Management expert
• Assist in the review and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports, and design transfer
• Review and approve design verification test protocols, reports and data from a logical point of view (Compliance, rationale, objectiveness and statistics)
• Partner within Quality and R&D to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met
• Review and approve biocompatibility protocols and reports
• Ensure compliance of IQ, OQ, tests method validation, Standard Operating procedures and work instructions regarding product development
• Maintain compliance to QMS procedures of the R&D Singapore site, and support the Singapore R&D Site - QA
• Support External audits by competent authorities and notified bodies
• Support internal audits at the local site, and other sites as required
• Review and approve other quality documents (e.g., IQ, OQ, PQ, WI, etc) within areas of responsibility
• Propose and execute quality/process improvements. Write/review policies/ processes/ procedures and related documents
• Manage and monitor the progress of the calibration and maintenance of testing equipment. Ensure calibration or maintenance records satisfy regulatory and QMS requirements (act as Equipment Control Administrator in Singapore)
• Participate in development projects and change control request meetings to support the resolution of engineering issues
• Collaborate with the post-market surveillance team and complaints investigation teams to maintain risk management process throughout a product’s lifecycle
• Provide support for other quality activities and improvement initiatives, quality data collection and trending, CAPAs, change controls, training, etc.
• Support initiatives as identified by management to support QMS and other regulatory requirements in Singapore

Requirements

Experience

• At least 4+ years of Industry experience working as QE Engineer in Medical Device/ Pharmaceutical product or optical engineering business field
• Experience in test method validation
• Experience in Design control, Design Transfer, Design and Development Process
• Demonstrated knowledge of Risk Management (ISO14971), Design control, Design and Development Process and Quality System (any one of ISO13485).
• Understanding and Knowledge of biocompatibility studies
• Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills
• Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management
• Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues
• Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities
• Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required
• Capable of clearly presenting and justifying quality requirements to management
• Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)

Skills/Accreditations

• Smooth communication ability
• Business software skills (e.g. Word, Excel and Power point)
• Experience with statistical software such as Minitab
• Voluntary working attitude with a creative idea
• Passionate working attitude to pursue a goal with patience.
• Flexibility for changes

Academic Qualifications

• A bachelor’s degree or higher in Chemical, Bioengineering, Mechanical, Optical Engineering or related fields.

Travel requirements

• 2-3 international travel annually mainly Thailand.

By submitting your application, you consent to HOYA Group collecting, disclosing, and retaining your personal data for employment assessment and verification purposes.

If you are shortlisted, we will contact you within three weeks of your application. Thank you for your application and understanding.

Job Duties:

• Manage the process for QMS audits, to ensure compliance of the organization’s Integrated Management Systems wrt ISO9001/TS16949/ VDA 6.3, Customer specific requirements.
• Identify areas/ system gaps for improvement and implementation. Establish and drive QMS enhancement and integration roadmap/milestones.
• Work closely with Operations and key stakeholders to maintain consistent manufacturing, quality policies and compliance
• Responsible for maintaining/improving fab performance though SPC program.
• Investigate root causes and resolve key fab-related quality issues and effectiveness of corrective and preventive actions. Manage Non-Conformance cases with respect to on-time closure with the relevant customers/Business Lines.
• Responsible for Outgoing and Periodic review OQA performance to drive defect reductions
• Responsible for Document Centre Management & Library Services
• Management of change among diverse cultures in a fast paced environment
• Co-work with related functions to support the wafer fabrication process to drive process/system optimization and effectiveness

Job Qualifications:

• Degree in Chemical / Electrical Engineering / Physics / Chemistry or equivalent
• 8+ years in semiconductor industry preferred
• Knowledge of wafer fabrication process essential
• Strong in project management skills, facilitation, analytical skills and system thinking

• Serve under the general supervision of the Supervisory Fire Inspector (Captain), who makes assignments based on the overall policy and general content of the fire prevention program.
• Operate within an assigned inspection area to include high-risk, conducting comprehensive fire/safety inspections to identify and correct hazardous conditions.
• Identify complex unique hazards and devises corrective measures.
• Conduct public education classes post-wide as well as on-the-job training classes for fire department personnel.
• Provide training in general fire/safety subjects as well as issues unique to a particular activity.
• Conduct review of architectural drawings and specifications to determine compliance with fire/safety regulations and evaluates special features impacting the fire protection mission.
• Respond to emergency incidents as part of a firefighting team, performs a full range of firefighting duties at all types of emergency incidents, maintaining a degree of firefighting proficiency sufficient to perform firefighting tasks.

• If selected at the GS-11 level, duties will be performed in a developmental capacity.
• Plans/executes engineering and technical functions related to engineering, manufacturing, and quality assurance.
• Develops and/or implements agency engineering and quality assurance policies, tools, and training program.
• Provides authoritative guidance and advice to management, customers, and Quality Assurance Specialists in functional area of expertise.
• Resolves complex technical problems associated with surveillance of major, critical contracts for program life cycle stages, next generation equipment, or DoD Weapon Systems.

• If selected at the GS-11 level, duties will be performed in a developmental capacity.
• Plans/executes engineering and technical functions related to engineering, manufacturing, and quality assurance.
• Develops and/or implements agency engineering and quality assurance policies, tools, and training program.
• Provides authoritative guidance and advice to management, customers, and Quality Assurance Specialists in functional area of expertise.
• Resolves complex technical problems associated with surveillance of major, critical contracts for program life cycle stages, next generation equipment, or DoD Weapon Systems.

• Designs/implements/maintains a risk-based surveillance program and assessment plan associated with the quality assurance provisions of contracts.
• Identifies opportunities for process improvements by analyzing data.
• As a member of a multi-functional or technical team, implements the overall Quality Program for diverse products and services to support the U.S. Government’s acquisition at one or more supplier facilities.
• Ensures contractor compliance with design, manufacturing, repair, overhaul, and modernization requirements.
• Independently audits/surveys contractor processes to ensure compliance with customer/contractual requirements.
• Investigates customer complaints/concerns about contractor quality performance and processes which impact user satisfaction, then provides data about the complaints.
• Provides technical support to DCMA team members, assisting with analyzing contractual issues, and determining the best course of action to support the contractor and customers.

• Performs the full range of field duties including construction management, quality assurance, and safety monitoring functions for complex Military Construction projects.
• Incumbent participates in design review conferences and discusses construction aspects of the design and foreseeable problems.
• Advises the Resident Engineer on plans and specifications, and performs determinations on whether methods and materials employed meet requirements of specifications.
• Make recommendations for changes in construction to meet field conditions
• Monitors the contractor’s schedule and uses contractual actions to address contractor schedule problems and slippages.
• Manages the submittal register and that submittals are reviewed on time.

This position can be filled within any of the current TIGTA offices throughout the country and is NOT a remote position.

As a Visual Information Specialist, you will:

• Use the available desktop publishing technology and equipment in the development and production of design for reports, publications, or other visual presentations.
• Design and produce graphics for electronic and print publications and visual presentations or equivalent.
• Take project concepts through its various stages of development, from preliminary rough layouts, through comprehensive layouts for client approval and on through final art.
• Develop interpretations of information, original ideas and concepts using illustrative materials.

This position can be filled within any of the current TIGTA offices throughout the country and is NOT a remote position.

As a Visual Information Specialist, you will:

• Use the available desktop publishing technology and equipment in the development and production of design for reports, publications, or other visual presentations.
• Design and produce graphics for electronic and print publications and visual presentations or equivalent.
• Take project concepts through its various stages of development, from preliminary rough layouts, through comprehensive layouts for client approval and on through final art.
• Develop interpretations of information, original ideas and concepts using illustrative materials.