Bachelor's degree in engineering, quality, or a related field.
5+ years of experience in supplier quality, manufacturing, or auditing roles.
Strong knowledge of ISO 13485, ISO 9001, and FDA requirements.
Skilled in SCAR, CAPA, FMEA, and audit processes.
Effective communicator, able to work with cross-functional teams and external suppliers.
Willing to travel as needed (up to 20%).
Responsibilities
Lead qualification of new suppliers and components, ensuring alignment with company requirements.
Plan, conduct, and report supplier audits, following up on findings and verifying corrective actions.
Manage and monitor supplier KPIs, identifying trends and leading continuous improvement plans.
Lead investigations of supplier non-conformances, implementing corrective actions and tracking SCARs to closure.
Partner with R&D, Operations, and Regulatory teams to ensure quality during product development and launch.
Ensure supplier processes comply with ISO 13485, FDA, and other applicable standards, advising suppliers on regulatory changes.
Benefits
Opportunity to work in a dynamic, cross-functional environment.
Engagement in continuous improvement initiatives.
Exposure to regulatory compliance processes in the medical device industry.
Full Job Description
Responsibilities
The Senior Supplier Quality Engineer (Senior SQE) is responsible for driving supplier compliance and continuous improvement. This role ensures suppliers meet the company's quality standards and regulatory requirements through effective qualification, auditing, performance monitoring, and corrective action processes. The Senior SQE plays a key part in risk mitigation and supports new product introductions, collaborating closely with R&D, operations, and regulatory teams.
Key Responsibilities:
Supplier Qualification & Approvals: Lead qualification of new suppliers and new components. Review supplier technical capabilities and quality systems to ensure alignment with company requirements.
Audits & Assessments: Plan, conduct, and report supplier audits (on-site and remote). Follow up on audit findings and verify implementation of corrective actions.
Supplier Performance Monitoring: Manage and monitor supplier KPIs including quality, delivery, and responsiveness. Identify trends and lead continuous improvement plans.
Issue Resolution & SCAR Management: Lead investigations of supplier non-conformances, working with suppliers to complete root cause analysis and implementing corrective actions. Track SCARs to closure.
Cross-Functional Collaboration: Partner with R&D, Operations, and Regulatory teams to ensure quality during product development and launch. Provide technical support and quality input for supplier-related matters.
Regulatory Compliance: Ensure supplier processes comply with ISO 13485, FDA, and other applicable standards. Stay up to date with regulatory changes and advise suppliers as needed.
Qualifications
Required Qualifications:
Bachelor's degree in engineering, quality, or a related field.
5+ years of experience in supplier quality, manufacturing, or auditing roles.
Strong knowledge of ISO 13485, ISO 9001, and FDA requirements.
Skilled in SCAR, CAPA, FMEA, and audit processes.
Effective communicator, able to work with cross-functional teams and external suppliers.
Willing to travel as needed (up to 20%).
Preferred Qualifications
Preferred Qualifications:
Experience in medical device or high-tech manufacturing.
Six Sigma, ASQ CSQP, or Lead Auditor certification.
Familiarity with risk management tools and supplier performance platforms.
Pay / Compensation The expected pre-tax pay rate for this position is $97,900 - $130,900 per year Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge, and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
