Staff Quality Engineer – Post Market

Senior Quality Engineer ensuring timely completion of design control deliverables and executing post-market activities at BD, a global medical technology company.

Posted 5/26/2026full-timeSan Diego • California • 🇺🇸 United StatesLead💰 $124,700 - $205,800 per yearWebsite

About the role

Key responsibilities & impact

Ensure the timely completion of design control (including risk management) deliverables in support of pre-release activities
Execute post-market activities
Collaborate on design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements
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

Requirements

What you’ll need

Bachelor’s degree in engineering field
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

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

risk managementdesign controlsquality engineeringdata analyticscomplaint trendingISO 14971ISO 13485regulatory compliancedocumentationvalidation strategies

Soft Skills

collaborationcommunicationleadershiporganizational skillspresentation skills