Quality Engineer

On-site at the Indianola facility 4 days per week Zip Code 15051

Quality Team is responsible for the quality of supplied materials and services that are used in the manufacturing of medical devices. This includes interactions with various parts of the organization from New Product Development through Life Cycle Engineering.

POSITION DUTIES & RESPONSIBILITIES:

• Lead supplier qualification activities for new components and processes to support production launch readiness of a new medical device.

• Plan, execute, and document component and process qualification activities

• Review and interpret supplier documentation to support qualifications such as FAIs, pFMEAs, Control Plans, Process Flow Diagrams, IQ/OQ/PQs.

• Ensure supplier process capability meets design and quality requirements through 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 and resolve discrepancies.

• Serve as the quality interface between the R&D organization and selected suppliers.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in engineering, or other related technical discipline required

• 4-7 of experience in a quality-related role within a regulated industry (medical device preferred).

• Strong working knowledge of qualification and validation methodologies, including IQ/OQ/PQs, pFMEAs, Control Planes, Capability studies (Cpk), Gage R&R and measurement system analysis, First Article Inspections.

• Ability to interpret engineering drawings, specifications, and technical requirements.

• Strong written and verbal communication skills, including supplier-facing interactions.

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