Staff Quality Engineer (Post Market)
About The Position
The Senior Quality Engineer will ensure the timely completion of design control (including risk management) deliverables in support of pre-release activities and will execute post-market activities. Roles and Responsibilities: Collaborate on design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements. Engage in design and development and post-market activities for both medical and non-medical Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Design Quality Engineer members that share in varying pieces of the risk management lifecycle Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership. Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams. Find opportunities for continuous improvement of the Risk Management Process
Requirements
- Bachelor’s degree in engineering field and 5 years of Quality, Design Controls, Risk Management experience within the medical device industry.
- Minimum of 5 years of Post-Market Quality, specifically complaint trending/data analytics.
- Advanced knowledge of risk management, design controls, regulatory, quality engineering polices, principles and standard methodologies.
- Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including ISO 14971 and ISO 13485.
- Strong oral and written communication and interpersonal skills.
- Technical problem solving.
- Ability to work in teams.
- Critical thinking.
- Ability to adapt to a rapidly changing environment.
- Desire to contribute to meaningful and innovative products.
Nice To Haves
- Experience with Hazard Analysis or FMEA and verification/validation.
- Quality certifications relevant to BD, such as ASQ Certified Quality Engineering, Certified Auditor, and Six Sigma credentials preferred.
Responsibilities
- Collaborate on design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements.
- Engage in design and development and post-market activities for both medical and non-medical.
- Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Design Quality Engineer members that share in varying pieces of the risk management lifecycle.
- Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.
- Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams.
- Find opportunities for continuous improvement of the Risk Management Process.
Benefits
- Comprehensive Total Rewards program
- Reward and recognition opportunities that promote a performance-based culture
- Competitive package of compensation and benefits programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
