Sr. Supplier Quality Engineer
Senior Supplier Quality Engineer Precision Life Sciences
Accountable for the development, execution and delivery of quality strategies for the Management of Suppliers and received goods, services and materials in accordance with cGMP. Partner with Operations, Product Development, Manufacturing Engineering, and Regulatory to assure all quality deliverables are met within cost, quality and schedule targets. Position will operate as a liaison among the various functions and the Quality Operations department to assure strategic alignment and compliance. Work with Supply Chain to ensure Integrity of Supply and continued compliance with current and evolving regulations pertaining to product throughout the Supply Chain. Oversee and/or assist with tasks related to the activities associated with operation of Quality System as directed by Quality leadership. Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree in Engineering will be essential for this position.
Primary Duties and Responsibilities
Supplier Quality System
- Execute requirements of the Supplier Quality Management System including oversight of suppliers that manufacture for and supply products and services .
- Coordinate all approval activities in accordance with global regulations and guidelines. Monitor for ongoing compliance to established agreements, regulations and expectations. Activities include regular oversight of supplier processes (i.e., deviation approval, on-site audits etc.)
- Partner & collaborate with Operations and Engineering in the selection of new suppliers.
- Provide leadership in directing and promoting Quality Improvement processes with suppliers to improve their quality and on-time delivery.
- Influence the organization across departments (Quality, Regulatory) to support supplier quality strategy and make sound decisions on supplier strategy and site direction.
- Assist with continued company certification to the appropriate Quality System Standards and Regulations and assist with all related inspections as required.
- Coordinate/assist the operation of Supplier Audit Systems. Provide support as required while conducting all such audits.
Non-Conformance / Supplier Corrective Action
- Understand/perform analyses and identify trends in the inspection of finished products, in-process materials and bulk raw materials, and recommend corrective actions as necessary.
- Drive the operation of the Quality System process related to Corrective/Preventive actions and product non-conformance control including; capturing data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
- Establish, monitor, and report on quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed.
- Partners with Operations, Product Development, Engineering and Regulatory to assure there is appropriate execution of controls and process validation.
- Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical device.
- Bachelor’s Degree or equivalent experience required
- ASQ Certification as a Quality Auditor, Quality Technician, Quality Engineer, or equivalent preferred.
Experience & Qualifications
- Minimum 5 years Medical Device or Pharmaceutical Manufacturing and/or other regulated industry or similar experience required.
- Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines
- Strong technical and general problem-solving skills required.
- Ability to work with company staff and communicate effectively throughout the organization.
- Excellent written and oral communication skills with attention to detail
- Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
- Experience with statistical analysis of data.
- Ability to work effectively in a global, matrix environment
- Ability to work independently
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts
Where you will go:
Position is located in West Chester, PA / Hybrid
Up to 30% travel as needed, with overnight stays
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Precision Life SciencesWest Chester, PA
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