Job Summary

Responsibilities

• Develop and implement quality assurance processes for medical device software in compliance with industry standards and regulations (IEC/ISO 62304 Medical Device Software Lifecycle and 21 CFR 820.30 Design Controls)
• Assure thorough testing and validation of software and hardware systems to ensure they meet specified requirements and are free from defects.
• Collaborate with cross-functional teams to define quality metrics, standards, and procedures throughout the software development life cycle.
• Assist with cross functional risk assessments and contribute to the creation of risk management plans related to software quality.
• Reviews to assure that verification test plans, verification test cases, and validation protocols are complete and will provide meaningful results to assure design output met the design input
• Stay updated on industry trends, regulatory changes, and best practices in medical device software quality.
• Participate in audits and inspections to ensure compliance with relevant quality standards and regulations.
• Investigate and analyze reported product defects, providing detailed and accurate reports to support corrective actions.
• Facilitate communication between development teams and regulatory affairs to address quality-related issues.
• Contribute to continuous improvement initiatives by leading complaint investigations and CAPAs.
• Review design specifications for clarity and testability 
• Participate in design reviews for new products
• Establish quality plans for new products
• Facilitate pre-and-post-market risk management activities
• Maintain records to assure regulatory compliance

Requirements

• Bachelor’s degree in Engineering or related field or Associates degree with 15+ years of relevant experience

•10+ years of related experience in the medical device industry or equivalent combination of education and

 experience

• Demonstrated knowledge of IEC/ISO 62304 Medical Device Software Lifecycle and 21 CFR 820.30 Design Controls

• Experience with FDA regulations, specifically medical device software

• Experience in compliance to GMPs

• Excellent leadership and communication skills

• Ability to mentor junior staff

• Able to use electronic systems including IT equipment to carry out duties

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

• Develop, implement, monitor, and report on various quality metrics. Identify opportunities for continuous improvement and customer satisfaction. Compile and represent data for monthly CAPA, Product and Design Review meetings
•  Develop and maintain detailed documentation and records, for both internal and external customers, throughout all phases of product design development.  Ensure that all quality and design control / change control requirements are met. 
• Analyze sub-system requirements, specifications, drawings, control specifications, medical device risk management files, and provide analysis of proposed designs to determine their ability to function as intended by considering use case scenarios and various other inputs. 
• Define and facilitate the CAPA process and associated record generation, such that CAPA findings will associate with product and process improvements in other areas of the organization.
• Serve as project manager for CAPAs and SCARs to drive risk assessments, root cause investigations, implementation, and verification activities in line with defined process timelines.  Work with other functions to ensure proper resources and expertise are allocated to CAPAs. 

• Create/maintain complex project schedules, while providing technical input regarding quality to strategic/project plans. Collaborate across organizational functions to achieve company and project objectives including effectively communicating status and issues to management as necessary. 

• This includes providing technical input regarding quality, to strategic/project plans while collaborating across organizational functions to achieve company and project objectives.
• Continually improve quality processes and identify risks to resolve issues that may negatively impact product quality strategy/project scope.
• Provide leadership to team members, guiding them in terms of prioritization, problem resolutions, process clarification, referrals to appropriate experts, etc. to ensure timely completion of responsibilities.
• Provide quality support for New Product Development. Incorporate knowledge of customer use and product design to predict product effectiveness and anticipate potential failures. Influence requirements definitions and ensure that reliability, quality, and safety requirements are met. Mentor and coach Engineering with the development of test protocols, reports, design specification clarity and testability.
• Act as a subject matter expert in Change Review Board as part of the change control process.
• Participate in design reviews for new products.
• Support and facilitates design verification & validation activities for hardware and disposable sets.
• Support manufacturing transfer activities such as IQ, OQ and PQ of manufacturing tools and processes, including calculating relevant sample sizes

Requirements

• B.S. degree in Engineering (materials, biomedical, or mechanical)
• 8+ years of specialized experience in the medical disposables/device products field or advance technical degree.
• Experience in compliant practices of design control and medical device risk management. 
• Excellent verbal and written communication skills. 
• Strong leadership and project management skills.
• Strong analytical capability and attention to detail.
• Ability to operate independently and exercise good judgment.
• Able to use electronic systems including IT equipment to carry out duties

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.