Supplier Quality Engineer

JOB TITLE: Senior Supplier Quality Engineer

DEPARTMENT: Quality Assurance

REPORTS TO: Quality Director

JOB SUMMARY

In this role, the Senior Supplier Quality Engineer provides quality leadership and governance to our medical device supplier management program. This role leads the selection and qualification of suppliers to ensure strong supply chain partnerships are established which will support future development and forecasted business growth while assuring product requirements are met. This role will oversee Supplier Quality activities for medical devices while ensuring regulatory and quality compliance is maintained throughout the supplier management program. They will lead efforts to drive improvements in the supply chain as part of product development and manufacturing activities, as well as lead implementation of supplier quality strategies and objectives.

They will partner with R&D, Quality, Procurement, Manufacturing, Engineering and our suppliers to maintain and improve supply chain management, including supplier qualifications, raw material and component qualifications, supplier audits, supplier corrective actions and supplier dashboard/scorecard implementation. As part of the team, this role will significantly contribute to the development, establishment, and maintenance of supplier quality engineering methodologies, systems, and practices and effectively integrate these practices into the development of the company's products.

The Senior Supplier Quality Engineer will have a significant contribution in establishing the infrastructure and processes to ensure a robust supplier quality program is integrated effectively and adequately supports product development, manufacturing at scale, and sustainment activities. They will be responsible for performing technical evaluations, analyses, and monitoring supplier related performance metrics to ensure quality objectives are achieved.

JOB RESPONSIBILITIES

• Ensure that suppliers deliver quality parts, materials, and services.
• Partner with Production & Planning to identify, select and evaluate suppliers to ensure suppliers can comply with the QMS, product requirements, and manufacturing requirements (current and future forecasted growth).
• Assess suppliers according to company standards and implement a supplier quality qualification process to ensure cost effectiveness.
• Lead supplier audits and drive resolution of supplier non-conformances, corrective actions, and audit findings, when applicable.
• Interface directly with suppliers to build successful partnerships, articulate the company's QMS requirements, review observed issues, provide feedback and enforce corrective/preventive actions.
• Monitor components from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur.
• Develop and prioritize an auditing schedule to ensure that critical suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Implement Supplier Quality Dashboards and Supplier Scorecards.
• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the product lifecycle and implement strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment and audit findings.
• Other duties as assigned.

SKILLS AND QUALIFICATIONS

• Minimum, Bachelor's Degree in engineering or science.
• Minimum, 5 years of related experience in medical device manufacturing.
• Working knowledge of Quality standards, i.e., QSR 21 CFR 820, ISO 13485, ISO 9001and ISO 14971.
• Demonstrated experience regarding supplier qualification process.
• Excellent written and verbal communication skills. Ability to interact professionally with all organizational levels.
• Great attention to detail. Good problem-solving and critical thinking skills.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to travel approximately 20 - 25%.

PREFERRED KNOWLEDGE, SKILLS AND ABILITIES:

• Master's Degree in engineering or science.
• 7 - 10 years of related experience in medical device manufacturing.
• FDA Class II/III medical device experience.
• ASQ CQA/CQE or equivalent certification.
• ISO 13485 Lead Auditor Certification.
• Knowledge of machining technologies and processes.