Principal Supplier Quality Engineer
Our client, a growing medical device company specializing in advanced cardiovascular disease detection systems, is currently seeking a Principal Supplier Quality Engineer. This person will be responsible for leading supplier quality initiatives, ensuring compliance with industry standards, and driving continuous improvement to support the development of life-saving technologies.
Qualifications:
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Utilize risk-based approach in the classification and management of suppliers.
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Resolution of quality issues including supplier non-conformances, corrective action requests, and CAPA.
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Lead the qualification of new suppliers, including supplier selection and approval.
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Conduct external supplier audits to ensure compliance. Independently manage resolution of quality issues observed during audit process to raise level of supplier performance to company standards.
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Execute and enforce Supplier and/or Distributor Quality Agreements.
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Maintain supplier quality records in accordance with FDA/GMP and EU MDR requirements.
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Lead the review of supplier change requests with a cross-functional team, including evaluation of change, implementation planning, and approval.
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Generate KPI’s and supplier metrics, including producing quarterly scorecards for supply base as defined.
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Consolidation of supply base through identification of redundant capabilities and initiating/supporting manufacturing or service transfers as needed.
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Initiate and drive process/yield improvement projects where possible.
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Where possible, propose and implement continuous improvements for responsible areas.
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Mentor and develop quality personnel and/or organizational partners.
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Role may require periodic meetings during off-hours to support or address issues arising at foreign manufacturers.
Requirements:
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Bachelor of Science degree in a technical discipline. Engineering discipline required.
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10+ years of quality engineering in life sciences industry, 5+ years supplier quality experience required.
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Able to research and understand foreign manufacturing processes and provide input on process improvements and/or defect resolution.
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Proven track record with supplier selection, approval, and management.
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Prior management or supervisory experience preferred.
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Strong written/verbal communication skills and demonstrated use of quality tools/methodologies.
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Working knowledge of FDA/QSR, ISO/EU MDR standards, process validation, product design control, CAPA, and FMEA methodologies.
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Proficient with Microsoft Office applications, and willingness to learn internal ERP and PLM systems.
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Certified Internal Auditor and/or experience performing Internal Audits strongly preferred.
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Current ASQ and/or six sigma certifications preferred.
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Ability to identify under-performing suppliers and work with them to improve or reduce defect occurrence rates, initiating transfer activities to alternative suppliers if necessary.
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Ability to work independently, managing all requirements of supplier management program.
If you are interested in this position, please send your resume to [email protected]
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