What are the responsibilities and job description for the Engineering Specialist, Quality position at Fresenius Kabi USA, LLC?
Job Summary
The Engineering Specialist, Quality supports the product development process, requirement planning and reviews, verification planning, review of test case methods, and 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.
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.
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.
Review verification test plans, verification test cases, and validation protocols to ensure completeness and meaningful results.
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.
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