Engineering Specialist, Quality
Fresenius Kabi USA
full-time
Posted on:
Location Type: Hybrid
Location: North Andover • Massachusetts • United States
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Salary
💰 $160,000 - $170,000 per year
About the role
- Develop and implement quality assurance processes for medical devices in compliance with industry standards and regulations
- 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
- Provide quality oversight for software deliverables, ensuring compliance with software lifecycle requirements
- Strengthen and maintain the QMS structure for design and software quality by defining workflows, templates, and governance for document control
Requirements
- Bachelor’s degree in Engineering or related field or Associates degree with 15+ years of relevant experience
- Greater than 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 operate independently exercising good judgement
- Ability to mentor junior staff
- 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 to include 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 management plansverification test plansCAPAsdesign specificationssoftware lifecycle requirementsGMP complianceIEC/ISO 6230421 CFR 820.30
Soft Skills
leadershipcommunicationindependent judgementmentoringcollaborationproblem-solvingattention to detailanalytical skillscontinuous improvementfacilitation