$80K — $100K *
Responsible for all aspect of Supplier Quality Engineering and NeoTract’s Supplier Management Program, including supplier evaluations, supplier selection/approvals, supplier maintenance, and supplier improvement/development activities. In this position, this person will be working in conjunction with the Operations and R&D functions in selecting and managing the supply base and driving supplier improvement activities/initiatives to support NeoTract’s manufacturing, product development and business objectives. The Sr. Supplier Quality Engineer serves as the primary quality and technical interface between NeoTract and the supply base.
• Serve as the primary quality and technical interface between NeoTract and the supply chain (subcontractors, suppliers, and service providers).
• Conduct supplier evaluations, selection, maintenance, qualification/validation and record keeping activities in accordance with established requirements and procedures.
• Conduct supplier audits and issue reports detailing audit findings and observations.
• Maintain and control supplier files contain supplier evaluation, approval, maintenance and correspondence in accordance with applicable procedures.
• Monitor, track and report on supplier performance and work with suppliers on quality issues.
• Oversee and manage supplier performance with respect to product quality and customer service/responsiveness, provide feedback to supplier as necessary and drive supplier performance levels to support business needs/objectives.
• Support supplier development and continuous improvement activities targeted at achieving department objectives and meeting business needs/objectives.
• Review and analyze production/manufacturing data to determine the primary factors affecting product quality, yield and cost and drive continuous improvement initiative with supplier as necessary
• Follows up on corrective and preventive actions related to supplier audit findings, nonconforming product/material and/or overall supplier performance to ensure effective resolutions and timely closure.
• Assist in the development, approval, and maintenance of material specifications, supplier requirements/instructions, quality assurance procedures, supplier agreements, and supplier documentation (e.g. Quality Plans, Work Instructions, Protocols, Reports, FMEAs, etc.).
• Work with Quality Control, Operations and Engineering personnel to identify opportunities for continuous improvement with respect to supplier quality, resolution of non-conforming material issues, and reduced and/or alternate inspection opportunities (dock-to-stock, skip lot inspections, etc.).
• Build and maintain effective cross-functional relationships with suppliers and internal departments such as Operations/Manufacturing, R&D/Engineering, Quality Control and Regulatory Affairs.
• Supporting department specific initiatives and projects as assigned.
• Domestic and International travel to suppliers and contract manufacturers as needed (40%)
• The guidance, recommendations, feedback, actions and decisions made by the Supplier Quality Engineer are critical in ensuring acceptable supplier performance, compliance with internal and external requirements/regulations, and the ability to successfully meet business needs and objectives.
• The successful management and development of suppliers has a direct impact on product costs and quality aspects of the business. Additionally, the impact of such guidance, decisions, and recommendations can have a direct effect on the company’s ability to design/develop new products and manufacture/produce existing products.
• The Supplier Quality Engineer position has signature authority for the Quality Department as it relates to supplier management and oversight activities.
Education / Experience Requirements
• Bachelor of Science in Engineering or Life Science discipline.
• 8 years overall experience in Quality Assurance; minimum 5 years experience in medical device manufacturing or pharmaceutical industries, minimum 3 years experience as a Supplier Quality Engineer.
• Experience with Class III sterile devices preferred.
• Trained and experienced Lead Auditors in conducting external Quality System assessments (preferably a Certified Lead Auditor).
• Experience with nitinol material processing, components, and/or products is desired.
Specialized Skills / Other Requirements
• Demonstrated knowledge of applicable regulations and standards such as FDA, QSR, ISO, MDD, & IVDD.
• Strong written, oral, and interpersonal skills.
• Strong analytical skills, problem solving techniques and statistical application experience.
• Knowledge in the areas of Supplier Management, Design Controls, Process Validation, manufacturing practices, and statistical techniques.
Valid through: 4/25/2021