Supplier Quality Engineer

Supplier Quality Engineer

JOB-10045715

Anticipated Start Date

January 26 ,2026

Location

Indianola , PA

Type of Employment

Contract

Employer Info

As a global leader in agriculture enterprise, our client is recognized for their multiple brands and renowned reputation. Their research and development teams combine knowledge and ingenuity to create the most innovative ideas. With their cutting-edge products, they have a common goal: improved quality of life for all.

Job Summary

If you're interested in a Supplier Quality Engineer job , then this is the best role for you ! The Pharma-Radiology Supplier Quality Team is responsible for ensuring the quality of supplied materials and services used in the manufacturing of medical devices. This role supports supplier quality activities across the product lifecycle, from New Product Development through Life Cycle Engineering, and serves as a key interface between internal teams and suppliers.

Job Description

• Lead supplier qualification activities for new components and processes to support production launch readiness of new medical devices.
• Plan, execute, and document component and process qualification activities.
• Review and interpret supplier documentation to support qualifications, including FAIs, pFMEAs, Control Plans, Process Flow Diagrams, and IQ/OQ/PQ documentation.
• Evaluate supplier process capability to ensure compliance with design and quality requirements using capability studies ( Cpk ) and statistical analysis.
• Collaborate with R&D Mechanical and Electrical Design Engineers and other internal stakeholders to ensure supplier capabilities and manufactured parts align with design intent.
• Resolve discrepancies between supplier output and design requirements.
• Serve as the quality interface between the R&D organization and selected suppliers.

Skills Required

• Four (4) to seven (7) years of experience in a quality-related role within a regulated industry (medical device experience preferred).
• Strong knowledge of qualification and validation methodologies, including IQ/OQ/PQ, pFMEAs, Control Plans, capability studies ( Cpk ), Gage R&R, measurement system analysis, and First Article Inspections.
• Ability to interpret engineering drawings, specifications, and technical requirements.
• Strong technical problem-solving skills.
• Excellent written and verbal communication skills, including supplier-facing interactions.
• Risk-based decision-making capability.
• Strong attention to detail and documentation rigor.
• Ability to manage supplier relationships effectively.
• Ability to collaborate across cross-functional teams.
• Ability to work independently in a project-driven environment.
• Preferred knowledge of manufacturing processes such as injection molding, PCB manufacturing and assembly, machining, and casting.
• Preferred familiarity with ISO 13485 and ISO 9001 standards.

Education/Training/Certifications

• Bachelor’s degree in Engineering or a related technical discipline.

Additional Requirements

• Must pass a drug screening and criminal background check
• Work schedule : 08:00 AM
• On-site presence at the Indianola facility four (4) days per week.
• Potential travel as needed, up to ten (10) working days per year.
• One (1) year contract with potential for extension to support ongoing new product development projects.

Pay Rate/Salary

• Estimated Salary: $57.76 to $65.76 per hour based on qualifications.

HarveStaff LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.