Quality Manager - Medical Device

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 Manager to develop and implement quality practices where necessary. To enforce company’s compliance to the GMPs, ISO requirements and other requirements necessary of a medical device manufacture of safe and effective devices. To assist and train employees where necessary on the GMPs and to follow the established system. To apply good technical solutions and to ensure empirical evidence is documented per written procedures.

RESPONSIBILITIES include but not limited to:

• 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 issuesall employees throughout all departments
• Becomes personally skilled in all inspection and testing procedures.
• Develops procedures and SOPs to control inspected and non-inspected product.
• Implements procedures and SOPs for QA/QC and ISO audits of Receiving, Receiving Inspection, Inventory, Manufacturing, manufacturing test, In-process inspection, Final inspection, engineering, Pre-production, new product development, Customer Service, Training, Purchasing, Shipping, and Documentation as well as other departments that effect quality, GMPs and other regulatory requirements.
• Monitors, maintains and assists with validation, sterilization, risk management and design activities.
• Coordinates and conducts quality audits per the defined schedule.
• Work with cross-functional teams to complete all assigned tasks
• Assists in the development, maintenance and implementation of processes and procedures in accordance with regulatory requirements.
• Coordinate and assist in corrective and preventative action activities and solutions
• To assist in the resolution, documentation, customer responses of product complaints.
• Establishes that all manufacturing processes and procedures are in accordance with properly released documentation.

REQUIREMENTS

• Experience working with quality system, ISO and quality assurance.
• Excellent communication and time management skills.
• Bachelor’s degree in related field of engineering, science, or regulatory affairs, or equivalent experience.
• Strong attention to detail.
• Minimum 5 years’ experience in medical device industry.
• Proficient in Microsoft Office Suite.

Location: Chanhassen, MN

PMT is an Equal Opportunity Employer