Job Summary
The Engineering Specialist, Quality supports: the product development process, requirement planning and reviews, verification planning, review of test case methods, & defect management and related risk assessments. Additionally, this position will support and improve active and disposable medical devices with an emphasis on design control and risk management processes supporting the North Andover Design Center Projects.
• Salary Range: $169,584 - $187,000
• Position is eligible to participate in a bonus plan with a target of 15% of the base salary (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.
Responsibilities
- Develop and implement quality assurance processes for medical devices in compliance with industry standards and regulations (IEC/ISO 62304 Medical Device Software Lifecycle, 21 CFR 820.30 Design Controls, ISO14971
Medical Device Risk Management, IEC 60601 Medical Device Electrical Safety , ISO10993 Biological Evaluation of Medical Devices, and IEC 62366-1: Application of Usability Engineering to Medical Devices )
- 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
Greater than 8 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 operate independently exercising good judgement
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 contribution, 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.
