Supplier Quality Engineer - Medical Device Industry

Join our team and play a key role in launching innovative medical devices! We're looking for a detail-oriented Supplier Quality Engineer who thrives in a collaborative environment and is passionate about ensuring top-tier quality standards.

*W2 Contracts Only

*Onsite 4 days per week in Indianola

Attention Candidates: Submit a Word Doc resume with your application. At the top of your resume you must include the following information: Years in a regulated environment; years working with medical devices (if applicable); years doing qualification and validation methodologies and given examples/explanations (including IQ/OQ/PQs, pFMEAs, Control Planes, Capability studies (Cpk), Gage R&R and measurement system analysis); years doing First Article Inspections.

What You'll Do

• Lead supplier qualification for new components and processes to ensure smooth production launches.
• Plan, execute, and document qualification activities for components and manufacturing processes.
• Review and interpret supplier documentation, including FAIs, pFMEAs, Control Plans, Process Flow Diagrams, and IQ/OQ/PQ protocols.
• Validate supplier process capability through statistical analysis and capability studies (Cpk).
• Work closely with R&D Mechanical and Electrical Engineers and other internal teams to align supplier capabilities with design intent and resolve any discrepancies.
• Serve as the primary quality liaison between R&D and selected suppliers.

What We're Looking For (REQUIRED)

• Education: Bachelor's degree in engineering or a related technical field.
• Experience: 4-7 years in a quality-related role within a regulated industry (medical device experience preferred).
• Skills:
  • Strong knowledge of qualification and validation methodologies (IQ/OQ/PQ, pFMEA, Control Plans, Cpk, Gage R&R, First Article Inspections).
  • Ability to interpret engineering drawings and technical specifications.
  • Excellent communication skills for supplier-facing interactions.

Preferred Qualifications

• Familiarity with manufacturing processes such as injection molding, PCB assembly, machining, and casting.
• Knowledge of ISO 13485 and ISO 9001 standards.

KEY COMPETENCIES:
* Risk-based decision making
* Technical problem solving
* Supplier relationship management
* Cross-functional collaboration
* Attention to detail and documentation rigor
* Ability to operate independently in a project-driven environment