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

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. 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.

Onsite work required during standard business hours.

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.

Why Join Bio-Techne:

• We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
• We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
• Bio-Techne is an E-Verify Employer in the United States.
• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
• This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status).
• If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact [e-mail] for assistance.
• Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.