Supplier Quality Engineer

The successful candidate will lead supplier qualifications and auditing activities, investigate supplier-related quality issues, manage corrective actions, and support new product introductions and manufacturing transfers.

Key Responsibilities

Supplier Quality & Supplier Management

• Qualify, assess, and onboard new suppliers through capability assessments, audits, and quality evaluations.
• Manage supplier performance, requalification activities, and Approved Supplier List maintenance.
• Serve as a key quality contact for supplier-related issues, risks, and improvement initiatives.
• Support supplier development efforts to improve quality systems, process controls, and performance metrics.

Quality Assurance & Compliance

• Conduct supplier and internal audits to verify compliance with ISO 13485, ISO 9001, MDSAP, and applicable regulatory requirements.
• Lead Supplier Corrective Action Requests (SCARs), including root cause review, corrective action verification, and effectiveness monitoring.
• Support CAPA activities, nonconforming material investigations, complaint investigations, and quality risk assessments.
• Assist during customer, regulatory, and third-party audits related to supplier management activities.

Process Improvement & Technical Support

• Analyze supplier quality trends and performance metrics to identify improvement opportunities.
• Support production part approval processes (PPAP) and new product introductions.
• Collaborate with Engineering and Manufacturing to improve product quality, reduce waste, and strengthen manufacturing processes.
• Participate in supplier transitions, sourcing activities, and supply chain risk assessments.

Qualifications

Education and Experience

• Bachelor's degree in engineering or a related technical discipline.
• 2-5 years of experience in Supplier Quality, Quality Engineering, or Process Engineering.
• Experience in a regulated manufacturing environment.

Knowledge, Skills, and Abilities

• Strong analytical, problem-solving, and communication skills.
• Knowledge of supplier quality systems, root cause analysis, corrective action processes, and quality improvement methodologies.
• Ability to manage multiple projects and work effectively across cross-functional teams.
• ASQ CQE, CSQP, Six Sigma Green Belt, or similar quality certification.
• Internal Auditor or Lead Auditor experience.
• Experience with PPAP, FMEA, SPC, and supplier development programs.
• Working knowledge of ISO 13485 and manufacturing environments.

Working Conditions

• Work performed in a laboratory and production environment with exposure to chemicals, reagents, and standard lab equipment.
• Standard schedule hours with occasional variation depending on production needs.
• Onsite work is required during standard business hours.
• Expected domestic travel is approximately 25% of the time (averaging one week-long trip per month) to regional offices or national client locations.

Physical Requirements

• Ability to lift and handle materials weighing 5-50 lbs.
• Ability to stand, walk, and perform repetitive laboratory tasks for extended periods.
• Manual dexterity required for laboratory equipment and fine measurement techniques.
• Ability to work at a computer for extended periods.