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.

• 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.
  
  

• 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.
    
    

• 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

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.