Located in Chanhassen, Minnesota, PMT Corporation was established in 1979 as a private company dedicated to the research and development of specialty products, devices and instruments used in the medical field. PMT Corporation is known for manufacturing and distributing high end, innovative products within the orthopedic, neurosurgery and plastic surgery markets.

DESCRIPTION:

PMT is hiring a Quality Engineer to maintain quality practices throughout all engineering deliverables. The Quality engineer will be directly responsible for validation of procedures, maintaining technical files and related reports, investigating product complaints, assisting the design engineer teams with report writing, and work with the quality and regulatory teams to ensure adherence to applicable standards within the engineering and product design processes. This is an in-office, salaried position at PMT headquarters in Chanhassen, MN from 8:00am – 4:30pm, Monday through Friday.

RESPONSIBILITIES include but not limited to:

• Completion of design control deliverables
• Execution of design verification and validation testing, related protocols, and reports
• Product Design History File and Technical File compilation and maintenance
• Follow quality management system procedures to ensure compliance and safety in all product design and production stages
• Investigation, resolution, and documentation of product complaints
• Maintain and update product usability and risk management files
• Initiate Engineering Change Orders as needed
• Resolve Corrective and Preventative Actions
• Follow ISO 13485 standards, FDA regulations, and the CE MDD/MDR
• Assist design engineering team as needed
• Assist the quality department to maintain accurate documentation through all processes.
• Establishes that all manufacturing processes and procedures are in accordance with properly released documentation.
• Coordinate efforts for external services (i.e. calibration, environmental testing, and standards) to perform tasks according to documented schedules.
• Monitor and trend quality indicators to report to management and to provide early warning for quality related issues.
• Maintain positive and cooperative communication and collaboration with all employees throughout all departments
• Work with cross-functional teams to complete all assigned tasks

REQUIREMENTS

• Bachelor’s degree in related field of engineering, science, or regulatory affairs.
• Strong attention to detail.
• Minimum 2-4 years’ experience, preferably medical devices.
• Experience working with ISO 13485 standards, and FDA and CE MDD/MDR regulations.
• Excellent communication and time management skills.
• Proficient in Microsoft Office Suite.

Location: Chanhassen, MN

PMT is an Equal Opportunity Employer