Quality Engineer II
Becton Dickinson · Tempe Headquarters
QualityFull-timeCompany career page
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Role summary
Becton Dickinson seeks a Quality Engineer II to lead quality assurance activities for medical device product lines. The role involves developing risk assessments, managing design and process validations, directing product investigations, and representing quality on cross-functional development teams.
What they're looking for
- Bachelor's degree in Engineering
- Minimum two years quality or engineering experience in medical devices, pharmaceuticals, or equivalent
- Advanced statistical and risk assessment techniques
- Working knowledge of ISO 13485 and ISO 14971 regulatory requirements
- Proficiency with quality engineering tools and root cause analysis methodologies
- Strong leadership and cross-functional team coordination abilities
- ASQ Quality Engineering Certification or equivalent (preferred)
What you'll be doing
- Lead development of risk assessments, test methods, and component qualifications
- Direct design validation, verification, and process validation activities
- Manage product investigations and assess changes against design specifications
- Serve as quality representative on product development teams and support regulatory submissions
- Coordinate supplier audits and develop procedures for regulatory compliance
Privacy & handoff
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