Pay Range:
$73,100.00 - $120,200.00
Position Summary:
The Supplier Quality Engineer will play a key role in ensuring the quality, reliability, and compliance of materials and components supplied throughout our manufacturing and supply chain operations. This position partners closely with Quality, Purchasing, Manufacturing, Engineering, and Supply Chain teams to manage supplier performance, drive continuous improvement, and ensure compliance with applicable regulatory and quality standards.
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. This role combines technical quality engineering expertise with supplier relationship management and offers the opportunity to make a direct impact on product quality, operational efficiency, and customer satisfaction.
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, preferably Medical Device, IVD, Biotechnology, or Pharmaceutical industries.
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 cGMP, ISO 13485, and FDA-regulated 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.
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.
