- Professional
- Office in Lake Geneva
Quality Engineer
Location: Lake Geneva, WI
Company: Medicoil
About the Role:
Medicoil is seeking a Quality Engineer to support and strengthen our Quality Management System. In this role, you’ll drive product and process improvements, lead root cause analysis and ensure compliance with key industry standards. You’ll work closely with Engineering, Manufacturing and Supply Chain teams to deliver high-quality, consistent results for our customers.
Responsibilities:
- Support and coordinate internal, customer, and process audits for the company’s Quality Management System.
- Help maintain compliance with industry quality standards such as ISO 13485 and IATF 16949.
- Develop, review, and improve quality procedures, inspection plans, control plans, and supporting documentation.
- Analyze and report inspection and testing results to ensure product and process quality.
- Participate in PPAP, validation, and documentation activities for new and existing products.
- Collaborate with Engineering, Manufacturing, and Supply Chain teams to address quality concerns and drive improvements.
- Lead corrective and preventive action efforts (CARs, PARs) and support continuous improvement initiatives.
- Assist in supplier assessments and maintaining the Approved Supplier List.
- Provide input on training and process improvements to strengthen overall quality performance.
Skills:
- Working knowledge of ISO 9001, IATF 16949 and/or ISO 13485 quality standards.
- Understanding of GMP, validation and verification processes (IQ, OQ, PQ).
- Proficiency with AIAG Core Tools, CQI special process requirements and general quality assurance principles.
- Ability to read and interpret blueprints, drawings and GD&T.
- Strong background in problem-solving, root cause analysis, PFMEA, control plans and process flows.
- Effective project management, training and communication skills.
- Detail-oriented, analytical and organized with strong teamwork and leadership abilities.
- Proficient in Microsoft Office and able to meet deadlines in a fast-paced production environment.
