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BD

Staff Quality Engineer – Post Market

BD

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

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Hard Skills
risk managementdesign controlsquality engineeringdata analyticscomplaint trendingISO 14971ISO 13485regulatory compliancedocumentationvalidation strategies
Soft Skills
collaborationcommunicationleadershiporganizational skillspresentation skills
Tools & Technologies
Quality Management Systems
Industry Keywords
medical device industrypre-release activitiespost-market activitiesrisk/benefit justificationcritical quality attributes

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