Description
Senior Supplier Quality Engineers (SQEs) conduct supplier audits and drivesuppliers to provide root cause analysis and timely corrective action of
non-conformances related to audit findings.
Essential Duties and Responsibilities:
* Complete audits of new and existing
suppliers per Stryker requirements to ensure conformance and compliance
* Drive timely closure of SCARs through the CAPA system
* Provide input to the creation of supplier contracts (e.g. Quality Agreements, Change Control,
etc.)
* Obtain process performance data from suppliers (e.g. SPC, FPY, fallout,
etc.)
* Analyze internally generated supplier performance data and metrics
(e.g. DPM, failure modes, trending, etc.)
* Provide suppliers with comparative data and metric performance for the purposes of executing improvement projects
* Complete component qualification via PPAP (e.g. process
validation, FAI, capability studies, etc.)
Qualifications (Education, Certifications and/or Experience)
* BS in Engineering, or Engineering related discipline, required
* 5-10 years of experience (preferably with medical device or auditing or ISO or FDA or quality or manufacturing)
* ASQ Certification preferred (i.e. CQE, CQA, etc.)
* Experience in medical device industry
* Familiarity with quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Plan
* Working knowledge of statistics and use of Minitab software: SPC, MSA, DOE, and
Process Capability
* Ability to navigate business management software (e.g.
Trackwise, JDE, Agile, etc.)
* Advanced working knowledge of MS Word, MS
Excel, MS Visio, and PowerPoint 2007