Be an early applicantLess than 25 applicantsPosted by Agency
Daley And Associates, LLC. · 2 days ago
Principal Supplier Quality Engineer
Bedford, MA
Full-time
Onsite
Senior Level
10+ years exp
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Responsibilities
Utilize risk-based approach in the classification and management of suppliers.
Resolution of quality issues including supplier non-conformances, corrective action requests, and CAPA.
Lead the qualification of new suppliers, including supplier selection and approval.
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.
Execute and enforce Supplier and/or Distributor Quality Agreements.
Maintain supplier quality records in accordance with FDA/GMP and EU MDR requirements.
Lead the review of supplier change requests with a cross-functional team, including evaluation of change, implementation planning, and approval.
Generate KPI’s and supplier metrics, including producing quarterly scorecards for supply base as defined.
Consolidation of supply base through identification of redundant capabilities and initiating/supporting manufacturing or service transfers as needed.
Initiate and drive process/yield improvement projects where possible.
Where possible, propose and implement continuous improvements for responsible areas.
Mentor and develop quality personnel and/or organizational partners.
Role may require periodic meetings during off-hours to support or address issues arising at foreign manufacturers.
Qualification
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Required
Bachelor of Science degree in a technical discipline. Engineering discipline required.
10+ years of quality engineering in life sciences industry, 5+ years supplier quality experience required.
Able to research and understand foreign manufacturing processes and provide input on process improvements and/or defect resolution.
Proven track record with supplier selection, approval, and management.
Strong written/verbal communication skills and demonstrated use of quality tools/methodologies.
Working knowledge of FDA/QSR, ISO/EU MDR standards, process validation, product design control, CAPA, and FMEA methodologies.
Proficient with Microsoft Office applications, and willingness to learn internal ERP and PLM systems.
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.
Ability to work independently, managing all requirements of supplier management program.
Preferred
Prior management or supervisory experience preferred.
Certified Internal Auditor and/or experience performing Internal Audits strongly preferred.
Current ASQ and/or six sigma certifications preferred.
Company
Daley And Associates, LLC.
Daley and Associates is a boutique executive search and contract staffing firm specializing in the placement of Accounting, Finance, Information Technology, Legal, Administrative and Life Sciences professionals.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Christyn Thatcher
CFO/COO
Hank Phillips
Principal & COO
Company data provided by crunchbase
