Description Summary of Position:
This position is for a Principal Supplier Quality Engineer with hands on experience and proven success in supplier management. Candidate should demonstrate proficient experience with quality management concepts, including but not limited to supplier quality, risk analysis, process control, root cause investigations, CAPA, and continuous improvement.
This position offers opportunity to establish/enhance policy and procedures for the Vascular Therapies Global Business Unit and provides exposure to multiple suppliers with diverse processes and healthcare product portfolios. The Principal Supplier Quality Engineer leads all supplier quality initiatives, developing, implementing, and maintaining methods/systems to ensure desired supplier performance levels are met and sustained.
Responsibilities:
•Support various Covidien manufacturing sites by providing expertise in Supplier Quality including:
-Audits
-Contracts (i.e. Supplier Agreements, Quality Agreements)
-Qualification
-Quality Planning
-Failure investigation
-Corrective and preventive action
-Supplier quality metrics and evaluations
-Risk assessment
•Travel to supplier sites to evaluate business and/or perform quality system audits
•Coordinate and facilitate periodic business reviews with key suppliers
•Identify and implement improvements in areas such as contracts, quality planning, supplier qualification, and related areas.
•Interact and form constructive working relationships with all level of leadership within Quality, R&D and Operations.
•Utilizes coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
•Travel 25% - 50%
Requirements Experience:
• Minimum 5 years relevant experience managing supplier quality in a regulated industry (preferably FDA regulated).
• Working knowledge of and auditing experience to QSR, ISO 13485, ISO 14971, and other relevant industry regulations and standards.
Preferred Qualifications:
•Certified Quality Auditor (CQA)
•Certified Quality Engineer (CQE)
•DMAIC Black Belt
Required Skills/Competencies:
•Working knowledge of medical devices regulations, ISO requirements, quality systems auditing, engineering principles, and manufacturing operations within a regulated industry.
•Working knowledge of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, FMEA, Technical Writing, Inspection and Testing, Pareto Analysis, etc.)
•Proven ability to directly lead and/or co-lead multiple tasks and process improvement projects.
•Ability to prioritize and execute in a fast-paced, changing environment.
•Proven ability to collaborate, coach, and mentor others.
•Solid conflict resolution skills.
•Excellent verbal and written communication skills.
Education required:
• BS/BA in science or engineering
Function Quality Division Med Dev - Patient Care & Safety Products