Senior Engineer, Quality
Fresenius Kabi USA
full-time
Posted on:
Location Type: Hybrid
Location: North Andover • Massachusetts • United States
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Salary
💰 $145,000 - $155,000 per year
Job Level
About the role
- Develop and implement quality assurance processes for medical devices in compliance with industry standards and regulations, including: IEC/ISO 62304: Medical Device Software Lifecycle, 21 CFR 820.30: Design Controls, ISO 14971: Medical Device Risk Management, IEC 60601: Medical Device Electrical Safety, ISO 10993: Biological Evaluation of Medical Devices, 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 and product development life cycle.
- Assist with cross-functional risk assessments and contribute to the creation of risk management plans related to software and product quality.
- Review and assure that verification test plans, test cases, and validation protocols are complete and provide meaningful results to confirm design outputs meet design inputs.
- Stay updated on industry trends, regulatory changes, and best practices in medical device software and product 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 and preventive actions (CAPAs).
- Facilitate communication between development teams and regulatory affairs to address quality-related issues.
- Contribute to continuous improvement initiatives by leading complaint investigations, CAPAs, and other corrective actions.
- Review design specifications for clarity, testability, and regulatory compliance.
- Participate in design reviews for new products and establish quality plans.
- Facilitate pre- and post-market risk management activities.
- Maintain accurate records to assure regulatory compliance throughout the product lifecycle.
Requirements
- B.S. degree in Engineering (materials, biomedical, or mechanical)
- Minimum 8 years of specialized experience in a medical disposables/device products field or advanced 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
Benefits
- 401(k) plan with company contributions
- Paid vacation
- Holiday and personal days
- Employee assistance program
- Health benefits including medical, prescription drug, dental, and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurance processestesting and validationrisk managementverification test plansdesign controlsmedical device software lifecyclebiological evaluationusability engineeringregulatory compliancecorrective and preventive actions (CAPAs)
Soft Skills
communication skillsleadershipproject managementanalytical capabilityattention to detailindependencejudgment