Supplier Quality Engineer — Audits & CAPA Leadership

Bio-techne; Harvard (MA); On-site; USD 73,000 - 120,000; Full time

Benefits offered by this job

401k

ESPP

HSA

FSA

Tuition reimbursement

Mentorship

Job summary

Bio-Techne seeks a Supplier Quality Engineer to ensure quality and compliance of materials across manufacturing and supply chain. You will lead supplier audits, onboarding, CAPA, and supplier development to improve product quality and reliability.

The role collaborates with Quality, Purchasing, Manufacturing, Engineering, and Supply Chain to drive continuous improvement and meet regulatory requirements in a fast-paced environment.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 2-5 years of experience in Supplier Quality, Quality Engineering, or Process Engineering.
• Experience in regulated manufacturing environments (Medical Device, IVD, Biotechnology, or Pharmaceutical).
• Knowledge of ISO 13485, FDA regulations, and quality improvement methodologies.
• ASQ CQE, CSQP, Six Sigma Green Belt, or similar certification is a plus.

Responsibilities

• 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.
• Conduct supplier and internal audits to verify compliance with ISO 13485, ISO 9001, MDSAP, and applicable regulatory requirements.
• Lead 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.
• Analyze supplier quality trends and performance metrics to identify improvement opportunities.
• Support PPAP and new product introductions.
• Collaborate with Engineering and Manufacturing to improve product quality and manufacturing processes.
• Participate in supplier transitions, sourcing activities, and supply chain risk assessments.

Skills

Analytical skills

Problem solving

Communication

Supplier quality systems

Root cause analysis

CAPA processes

Auditing

PPAP

FMEA

SPC

Regulatory compliance

Education

Bachelor's degree in Engineering or related technical discipline

Job description

Bio-Techne seeks a Supplier Quality Engineer to ensure quality and compliance of materials across manufacturing and supply chain. You will lead supplier audits, onboarding, CAPA, and supplier development to improve product quality and reliability.

The role collaborates with Quality, Purchasing, Manufacturing, Engineering, and Supply Chain to drive continuous improvement and meet regulatory requirements in a fast-paced environment.