Supplier Quality Engineer

Job Description

Job Description

The Supplier Quality Engineer (SQE) ensures the reliability, compliance, and superior performance of supplied components and assemblies, with a heavy emphasis on electromechanics and injection molding. The SQE works closely with Procurement, Quality Assurance, Engineering, and external suppliers to improve quality, optimize processes, and meet stringent industry standards.

Essential Duties and Responsibilities

• Lead the evaluation, qualification, and selection of new and existing suppliers through audits, assessments, and risk-based analysis.
• Review and approve supplier manufacturing processes, focusing on electromechanical assembly and molding parameters.
• Plan, schedule, and conduct supplier audits to evaluate compliance with quality management systems, regulatory standards, and contractual requirements.
• Partner with the Quality team on the inspection and testing of incoming materials, components, and products, ensuring conformity to specifications and regulatory requirements, ensuring timely resolution of any discrepancies or non-conformances with suppliers.
• Lead investigations of supplier-related quality issues, utilizing root cause analysis tools to drive effective corrective (CAR) and preventive actions (PAR). Track and report the status of actions related to nonconforming materials or processes (NCPs) to ensure timely closure.
• Develop and monitor key performance indicators (KPIs) for supplier quality, delivery, and responsiveness. Generate supplier scorecards and lead regular performance reviews, driving improvement initiatives as necessary.
• Maintain documentation of supplier quality activities and support compliance with relevant standards and audits.
• Ensure supplier compliance with regulatory and quality standards, including FDA 21 CFR Part 820, ISO 13485, QMS, and GMP requirements.
• Partner with Procurement, Quality Assurance, R&D and Engineering to ensure supplier quality requirements are integrated throughout the product lifecycle.

Requirements

Benefits

Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid parental leave , a wellness stipend and tuition reimbursement. Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth. Sentec focuses on delivering impactful healthcare products and improving patient care.

By choosing a career at Sentec, you’re not just choosing a job – you’re embracing the chance to make a real impact, contributing to the development of innovative medical solutions that support the wellbeing of individuals worldwide.

Sentec is a Swiss-American medical device company specializing in respiratory care. Since its founding in 1999, Sentec utilizes a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas. Sentec provides healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.