Position Description

The Engineering Specialist, Quality supports the following: Product development process, requirement planning and reviews, verification planning, review of test case methods, and defect management and related risk assessments. And this role will support and improve active and disposable medical devices with an emphasis on design control and risk management processes.

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

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