SR. QUALITY ENGINEER:

On behalf of our Medical Device client, Procom is searching for a Sr. Quality Engineer for a 6-month role. This position is an onsite position at our client’s Sturtevant, Wisconsin office, 53177.

SR. QUALITY ENGINEER - JOB DESCRIPTION:

The Senior Quality Engineer will provide quality engineering and technical support across various departments, including Operations, Sustaining Engineering, R&D, and New Product Introductions. This role focuses on ensuring compliance with standards and regulations, driving quality improvements, and fostering cross-functional collaboration.

SR. QUALITY ENGINEER - MANDATORY SKILLS:

• Bachelor of Science in Physical Science, Engineering, or equivalent experience.
• 3–5 years in a Quality Engineering role.
• 6–7 years in the medical device, pharmaceutical, or related industry.
• Strong technical writing and problem-solving skills.
• Proficiency in NCR/CAPA processes and investigations.
• Knowledge of ISO 13485, FDA QSR, and GMP requirements.
• Skilled in Microsoft Office Suite, Adobe, and Quality System Management Software.

SR. QUALITY ENGINEER – NICE-TO-HAVE SKILLS:

• Experience with electromechanical devices.
• ASQ Certified Quality Engineer (CQE) or equivalent.
• Familiarity with system software, firmware, and hardware integration.
• Understanding of statistical sampling for verification and validation.

• Review and support Change Control activities, including product design updates and supplier management.
• Evaluate technical documentation for compliance, accuracy, and design control.
• Partner with R&D and NPI for product verification, validation, and introductions.
• Provide quality engineering support for supplier changes and quality improvement initiatives.
• Support or lead NCR and CAPA processes, including investigations and root cause analysis.
• Support risk management activities across products and processes.
• Assist during regulatory inspections and internal/vendor audits.
• Ensure compliance with ISO 13485, FDA QSR, GMP, and other international standards.
• Deliver training and support broader Quality Management initiatives.