Principal Engineer, Supplier Quality

$114,714 - $160,600/Yr

Microvention - Aliso Viejo, CA

Full-time - Senior

Aliso Viejo, CA

Miscellaneous Manufacturing

About the position

The Principal Engineer, Supplier Quality at MicroVention, Inc. is responsible for leading Supplier Quality Engineering projects aimed at enhancing supplier performance, supporting product launches, and managing supplier qualifications. This role involves conducting supplier audits, performing risk assessments, and driving root cause analysis to resolve quality issues. The engineer will collaborate with various departments to ensure compliance with quality standards and regulations while reporting on key supplier performance metrics.

Responsibilities

• Lead Supplier Quality Engineering projects to improve supplier performance.
• Support product launch and supplier qualification processes.
• Organize and report key supplier performance metrics to the Quality organization and other departments.
• Perform supplier audits to evaluate quality systems, processes, services, and supplier capabilities.
• Assist with the Material Review Board (MRB) process to resolve issues with supplier-related components and services.
• Drive supplier root cause analysis and corrective action processes to prevent recurrence of quality issues.
• Perform supplier risk assessments and participate in supplier selection.
• Oversee supplier monitoring, SCARs, NCRs, and evaluate the impact of supplier change requests.
• Assist with management of approved suppliers via the Approved Supplier List (ASL).
• Execute SCARs and review supplier quality performance, escalating based on risk as needed.
• Work with R&D, Operations, and Procurement to ensure compliance for materials/components and services.
• Support regulatory compliance gaps at suppliers.
• Support supplier improvement programs as needed.
• Comply with applicable laws and regulations and adhere to Quality Management System processes.

Requirements

• Bachelor's degree in Engineering or a related science discipline.
• Minimum ten (10) to twelve (12) years of total supplier quality experience in a medical device or pharmaceuticals manufacturing environment.
• Six Sigma Greenbelt certified or equivalent knowledge.
• Excellent written and verbal communication skills.
• Working knowledge of global medical device regulations, requirements, and standards such as ISO 9001, ISO13485, ISO14971, QSR, and MDD.
• Expertise in root cause analysis, corrective/preventive action methods, and problem-solving with quality tools such as DMAIC, CAPA, FMEA, 5 WHYs, MSA, SPC.
• Experience with risk assessment files (dFMEA, sFMEA).
• Experience with engineering or supplier change processes.
• Audit experience in quality assurance activities for medical device and drug products.
• Experience with statistical techniques and process validations.
• Strong working knowledge of FDA and cGMP regulations and documentation practices, including SOP creation.
• Proficient with MS Word, Excel, Outlook, Teams, and statistical software.

Nice-to-haves

• Master's degree a plus.
• PMP Certification.
• Six Sigma Black Belt Certified.
• ISO13485 Certified Lead Auditor.
• Certified Quality Engineer.
• Advanced understanding of verification & validation, statistical techniques, and risk management.

Benefits

• Competitive salary range of $114,714 - $160,600 based on experience, education, and skill sets.