Supplier Quality Engineer
Michigan, Kalamazoo-Battle Creek
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Supplier Quality Engineer for a 6 month + Contract. This position is to support the revision and review of 2000 SKU' s for parts to comply with the new EU MDR standards. Candidates should have 3-6 years experience working in the medical device industry as a supplier quality Engineer. Responsibilities will include working with suppliers to update labeling/markings on all devices/parts and drive the PPAP process and updating inspection plans
Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Provide support for all Supplier Quality related activities. Assist in Receiving Inspection operations, supplier survey/ audit responsibilities, and new product development operations.
Ownership for supplier quality performance and measurement including KPI s and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews
Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.E. FDA, IMB, Notified bodies, etc)
Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes
Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders
Participate in the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non conforming products.
Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers.
Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions .
Deliver continuous improvement activities focusing on supplier quality
Participate as required in SCRB in conjunction with key stakeholders
Support ECR process in local change control systems
Participate in supplier audit program planning, execution and closure
Participate in supplier reviews for assigned suppliers as required
Participate in cross functional projects both locally & globally as required
Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.
QUALIFICATIONS / WORK EXPERIENCE
BS in engineering, or engineering related discipline required.
3+ years of relevant experience in Quality, Project Management, or Engineering.
Experience working onsite developing suppliers preferred.
Experience in production and process controls.
Expertise in problem solving and root cause analysis
Working knowledge of quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control Charts.
Demonstrated collaboration, negotiation, and conflict resolution skills.
Ability to lead, champion change, and execute strategies to meet goals.
Critical thinking and strong analytical skills.
Familiarity with quality systems; ISO13485 & ISO9001 experience preferred.
Working knowledge of statistics and use of Minitab software: SPC, MSA, DOE, and Process Capability.
Process knowledge in assigned commodity (i.E. Plastics, metals, electronics, PCBAs, etc.)
Advanced working knowledge of MS Word, MS Excel, MS Visio, and PowerPoint 2007 .
ISO-13485 Lead Auditor certification preferred.
Experience conducting supplier audits and internal audits preferred.