We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details Drive rigorous and context-specific supplier evaluation and selection activities to ensure the highest levels of quality from our supply base. Perform supplier qualification via Technical and Quality Capability Assessment and audits to evaluate supplier capability to meet Haemonetics and regulator expectations. Approve new suppliers. Key contributor on NPD (New Product Development) projects, ensuring rigorous performance and APQP deliverables (CTQ, PFMEA, control plan, GRR, FAI, IQ/OQ/PQ, PPA, etc.), in collaboration with Procurement, Manufacturing and R&D. Support R&D to ensure all requirements and specifications are documented both at Haemonetics and at suppliers. Ensure compliance to product specifications and quality systems requirements Lead activities to identify supplier process quality risks via PFMEA, and ensure mitigation / mistake-proofing in compliance with corporate procedures regarding supplier activities. Establish and maintain supplier viability for Approved Supplier List by ensuring the right quality-related agreements are in place, the supplier’s Quality System is adequate, and ongoing supplier performance is monitored. Drive rigorous 8D problem solving activities for Supplier Corrective Action: containment, root cause, corrective and preventive actions and effectiveness verification. Review nonconformance’s and customer complaints to determine issues and action plans. Daily quality support for issues arising in incoming inspection and on the production floor. Serve on the Site Material Review Board (MRB) and work to ensure ongoing supplier program transparency and open communication between cross-functional departments. Conduct external supplier audits to ensure finished device, component and service quality. Focus is on product/service-specific audits and QMS compliance. Monitor supplier performance and provide supplier program metrics and periodic reports. Provide feedback to suppliers and drive action plans for improvement. Initiate and drive continuous process & yield improvement projects throughout Haemonetics supplier base to reduce Cost of Poor Quality (e.g. scrap costs), help improve product consistency and maintain ongoing conformance to requirements Serve as the supplier quality representative during internal audits and for designated suppliers as necessary. Lead teams/projects related to supplier issues and improvement initiatives. Deploy TQM tools including six sigma. Ensure compliance to QMS processes and lead/support QMS process improvements. Work closely with cross-functional teams across departments, including senior management levels, to maintain high levels of supplier performance and professionalism at all times. A positive attitude is important while working in a fast-paced manufacturing environment and dealing with shifting priorities. QUALIFICATIONS EDUCATION Bachelor's Degree, or Associates Degree and demonstrated knowledge / experience Mechanical, Electrical, Industrial or Biomedical Engineering EXPERIENCE Required/Preferred 7-10 years Quality assurance/supplier quality engineering experience Required Experience in regulated environment Strong background with ISO9001, ISO 13485, FDA 21 CFR Part 820 and CAPA processes. Required Commodities and Technologies injection molding, tubing extrusions, blow molding Disposable Set Assembly, bag welding Finished Goods Packaging Medical Device Box Build (HLA & TLA), SMT, Soldering (Reflow, Wave & Manual) Strongly preferred Knowledge of APQP, PPAP Lead activities for CTQ, PFMEA, control plan, GRR, FAI, IQ/OQ/PQ, etc. Strongly preferred TRAINING/CERTIFICATIONS List Each Training/Certification Required/Preferred Black or Green Belt Six Sigma certification Preferred CQE or CQA EEO Policy Statement Pay Transparency: Residents of certain locations, including Colorado and New York City, may be entitled to additional information about the potential range of compensation and benefits associated with this position. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. – 5 p.m. ET or email AskHR@Haemonetics.com. Conditions of Employment: Haemonetics’s requires COVID-19 vaccination for all U.S. employees who work in the presence of other colleagues or customers, unless the employee is approved for a medical or religious exemption, pursuant to applicable law. While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, customers and communities as we continue to make health and safety our top priority.