Bruker · 2 days ago

Operations Quality Engineer II

Bothell, WA

Full-time

Onsite

Mid Level

$78K/yr - $127K/yr

3+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

ChemicalLife Science

Insider Connection @Bruker

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Support Manufacturing and Operations in navigating the Quality System including SCARS, nonconformances, deviations, change requests, CAPAs, and validations.

Monitor SCARS, nonconformances, deviations, complaints, and trends to identify and recommend corrective and / or preventive actions.

Conduct root cause investigations and analyses of issues as assigned.

Conduct risk assessments for SCARs, nonconformances, deviations, and document changes.

Provide Quality leadership on process, test method, and equipment validations.

Work with Supply Chain and suppliers to resolve raw material issues.

Manage the review and approval of Molecular diagnostic &/or Instrument DHRs (Batch Records).

Implement appropriate process monitoring and control methods consistent with the level of process/product risk using customer feedback.

Support customer complaints investigations and supplier audits

Collaborate with Manufacturing, Manufacturing Engineering, New Product Introduction, Procurement, Quality, and Supply Chain partners as well as vendors on the above activities

Basic application of statistical tools and methods.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Medical Device IndustryBiotechnology IndustryProduct DevelopmentQuality EngineeringRisk AssessmentRoot Cause AnalysisProcess Flow MapsDesign ControlChange ControlProcess ValidationTech Transfer-vitro Molecular Diagnostic ManufacturingQuality SystemFDA 12 CFR 820ISO 13485ISO 14971EU MDDCMDRIVDDASQ CertifiedCQECertified AuditorQuality SupportMolecular Diagnostics

Required

BS in Life Science or Engineering discipline

At least 3 years of experience in the medical device or biotechnology industry

Experience with product development within a regulated industry

Hands on experience with Quality Engineering tools such as; Risk Assessment (pFMEA), Root Cause Analysis (5 Whys, FTA, Ishikawa, Pareto, etc.), Process Flow Maps, etc.

Strong knowledge of design control, change control, process validation and tech transfer, and in-vitro molecular diagnostic manufacturing.

Working knowledge of Quality System from design control to release of finished product, including FDA 12 CFR 820, ISO 13485, ISO 14971,the EU MDD, CMDR, & IVDD