Supplier Quality Engineer - (Clinton, PA)

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Job Summary:

Perform supplier quality related activities for medical device purchased finished goods, components and related services, ensuring high quality for customers and Haemonetics factories. Responsible to ensure that Supplier Selection, Approved Supplier List (ASL) qualification, material qualification, supplier-caused quality issue resolution, supplier audits and other related activities are completed rigorously and in a compliant way per medical industry regulations (i.e. FDA, EUMDR, etc.) and per Haemonetics Quality System.Preference for candidates currently based within commuting distance to Clinton, PA. Clinton, PA is located South of Metro Pittsburgh area, approximately 20 miles from downtown and just Noth of the WV border.

Primary Responsibilities:

• Actively participant and occasionally leads supplier selection and ASL (Approved Supplier List) qualification activities for new suppliers. Contributes to Technical and Quality Capability Assessment.

• Work with other colleagues in CME (Contract Manufacturing Engineering), AME (Advanced Manufacturing Engineering) and R&D for product development and improvement projects to ensure supplier compliance to product specifications, manufacturing processes and quality systems requirements defined by Haemonetics, the FDA and other regulatory authorities.

• Participate in risk management activities to identify design and process risks and ensure mitigation in compliance with corporate procedures in regard to supplier activities.

• Conduct external supplier audits as assigned to ensure ongoing product excellence and QMS compliance. Manages findings to closure via an 8D (Eight Disciplines) problem solving approach.

• Drive rigorous 8D problem solving activities for Supplier Corrective Action for supplier-caused quality issues.: containment, root cause, corrective and preventive actions and effectiveness verification. Review nonconformance's and customer complaints to determine issues and action plans.

• Monitor supplier performance, provide feedback to suppliers and drive action plans for improvement.

• Ensure compliance to QMS processes and support QMS process improvements.

• Work on projects related to suppliers and Haemonetics' supplier management program: CAPA, supplier transfer, quality system excellence, supplier-initiated process changes, and cost reduction. This would include oversight and review of supplier deliverables. Provide supplier program metrics and periodic reports.

• Work closely with suppliers to ensure the right parts meeting specifications are delivered on time.

• Work closely with cross-functional teams across departments, including senior management levels, to maintain high levels of supplier performance and professionalism at all times. Communicate effectively and act as liaison between supplier and internal teams.

• A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.

• Ensure operational, functional and compliance excellence.

• Comply with all ISO 14001 requirements.

• Comply with internal environmental management system requirements, as applicable.

• In addition to the below mentioned responsibilities, the incumbent may be asked to perform other function-related activities as reasonably required by business needs.

Qualifications:

• Bachelor's Degree in technical, scientific, or related field, required. Master's Degree, preferred.

• 2+ years of Quality Assurance or Supplier Quality experience, required. In lieu of this experience, candidates with internship experience in supplier quality may be considered.

• Experience within Medical device, Pharmaceutical, or Biotechnology, preferred.

• Experience with Statistical Analysis using tools such as Minitab, preferred.

• Experience with corrective actions and audits, preferred.

• Experience within IQ/OQ/PQ, preferred.

• This role will be onsite in Clinton, PA/ SW Pittsburgh.

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