Impactful Supplier Quality Engineer

Bionostics, Inc.; Harvard (MA); On-site; USD 73,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with ESPP

HSA

FSA

Tuition reimbursement

Mentorship programs

Job summary

Bio-Techne in the United States is seeking a Supplier Quality Engineer to ensure the quality, reliability, and regulatory compliance of materials and components across manufacturing and supply chain operations.

You will lead supplier qualifications and audits, manage CAPA/SCAR activities, support PPAP and new product introductions, and collaborate with Quality, Purchasing, Engineering, and Manufacturing to drive improvements and on-time supplier performance.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 2-5 years in Supplier Quality, Quality Engineering, or Process Engineering.
• Experience in regulated manufacturing environments (Medical Device, IVD, Biotechnology or Pharmaceutical).
• Knowledge of supplier quality systems, root cause analysis, corrective action processes, and quality improvement methodologies.
• ASQ CQE, CSQP, Six Sigma Green Belt or similar 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.

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.
• Lead Supplier Corrective Action Requests (SCARs) with root cause review and verification.
• Support CAPA activities, nonconforming material 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 improvements.
• Support PPAP and New Product Introductions, and collaborate with Engineering/Manufacturing.

Skills

Analytical thinking

Problem solving

Communication skills

Cross-functional collaboration

Project management

Auditing

Education

Bachelor's degree in Engineering

Tools

PPAP

FMEA

SPC

Job description

Bio-Techne in the United States is seeking a Supplier Quality Engineer to ensure the quality, reliability, and regulatory compliance of materials and components across manufacturing and supply chain operations.

You will lead supplier qualifications and audits, manage CAPA/SCAR activities, support PPAP and new product introductions, and collaborate with Quality, Purchasing, Engineering, and Manufacturing to drive improvements and on-time supplier performance.