Supplier Quality Engineer

 

Stryker Sustainability Solutions is the leading provider of reprocessing and remanufacturing services for medical devices as well as comprehensive recycling and redistribution initiatives. Stryker was the first global Original Manufacturer (OM) to offer innovative, cost-effective programs, such as reprocessing and remanufacturing, to help meet the resource management demands of its hospital partners. Stryker’s programs specifically target inefficient practices and reclaim and redirect consumable and financial resources in order to promote healthy and responsible hospitals. 

Job Summary
Supplier Quality Engineers (SQEs) conduct supplier audits and drive suppliers to provide root cause analysis and timely corrective action of non-conformances related to audit findings (supplier corrective action requests). SQEs assess inspection and qualification criteria to improve efficiency while maintaining quality and work with suppliers to improve commodity quality. SQEs act as a liaison between Operations, Engineering, Purchasing, and suppliers to resolve and prevent quality issues.

Essential Duties and Responsibilities
Responsibilities related to Supplier Assessment / Qualification:
– Complete audits of new and existing suppliers per Stryker requirements to ensure conformance and compliance
– Identify and issue supplier corrective action requests (SCARs), as required, and drive suppliers to identify, correct, and prevent the root cause
– Drive timely closure of SCARs through the CAPA system
– Train and educate suppliers on GMP, regulatory requirements, and Stryker expectations
– Provide input to the creation of supplier contracts (e.g. Quality Agreements, Change Control, etc.)

Responsibilities related to Supply Base Development and Performance Improvement:
– Participate in and provide feedback to the supplier selection process
– Visit suppliers to resolve issues as needed
– 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
– Partner with other engineering functions as needed to resolve (non-audit related) supplier non-conformances

Responsibilities related to Operations Quality Efficiency:
– Partner with other engineering functions as needed to identify opportunities for reduced inspection of purchased materials based on risk and quality performance
– Partner with other engineering functions to execute supplier change requests related to manufacturing, process, or supplier requested changes
– 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
– 0-5 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 Quality, Project Management, or Engineering preferred
– Experience in medical device industry preferred
– Experience working onsite with suppliers preferred
– Collaboration, influence, negotiation, and conflict resolution skills
– Ability to lead, champion change, and execute strategies to meet goals
– Critical thinking and strong analytical skills
– Strength in problem solving and root cause analysis
– 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
– Excellent communication skills, verbal and written
– Excellent time management and organization skills, with high emphasis on attention to detail
– 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

Work Environment
– Various environmental conditions – office, production floor, warehouse, lab, supplier sites
– While performing the duties of this job, it may be required to stand, walk, or sit occasionally for long periods of time. It may also be required to use hands or fingers to handle, or feel objects, reach with hands and arms, balance, stoop, kneel, or crouch
– May occasionally lift and/or move up to 10 pounds
– Long periods of computer work
– The noise level is usually moderate
– May be exposed to Hazardous materials. Consult MSDS in work area
– Exposure to used medical devices
– Exposure to cleaning agents
– Protective equipment is required, as indicated by area procedure
– Subject to changes in procedures or work environment
– May need to operate small hand tool, inspection equipment and common office equipment
– Operate in a fast paced environment, sometimes requiring extended work hours

If interested, please apply online at