Becton Dickinson

Staff NPI Process Quality Engineer

USA CA - San Diego (BDB), USA · Staff+

Sponsorship not specified$130k-$207kDetected 15 days ago

Data EngineeringProduct ManagementProcess ImprovementFDA RegulatoryFlow CytometryMedical DevicesResearchCommunicationCollaborationProblem SolvingLean ManufacturingRegulatory Affairs

About the role

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters.
With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics.
Advancing the world of health™ is our Purpose, and it's no small feat.

Responsibilities

Collaborate with external and internal partners to define product requirements, intended use, and clinical performance criteria.
Ensure compliance with design control processes per FDA 21 CFR Part 820, ISO 13485, and IVDR.
Support risk management activities (ISO 14971), including hazard analysis, FMEA, and risk mitigation strategies.
Support verification and validation (V&V) planning and execution, including analytical and clinical performance studies.
Review and approve design documentation, including DHF elements, specifications, and test protocols.
Lead and coordinate supplier qualification, incoming inspection, and quality oversight of critical components.
Drive root cause analysis and CAPA for design-related issues during development and transfer.
Support regulatory submissions (e.g., PMA, 510(k), IVD-CE marking, China) with quality documentation and technical input.
Strong experience in design control, risk management, and regulatory standards (FDA, ISO, IVDR, China).
Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

Requirements

Bachelor's degree in Engineering, Life Sciences, or related field.
Experience work ing in cross-functional teams and managing external partnerships utilizing e xcellent communication, documentation, and problem-solving skills.
At BD, you'll discover a culture in which you can learn, grow and thrive.

Nice to have

Preferred Skills/Knowledge:

Skills

Master's degree in Engineering, Life Sciences
E xperience in Software quality assurance
ASQ certification in Lean Six Sigma G reen B elt /B lack B elt
Experience in flow cytometry instruments and/or clinical assays.

Compensation

$129,600.00 - $207,400.00 USD Annual

Benefits

Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service.
BD is one of the largest global medical technology companies in the world.
Minimum 5 years of experience in Quality Engineering within the IVD or medical device industry.

Company info

We are the people who give possibilities purpose

Visa & Work Authorization

We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientatio

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