Quality Compliance Specialist

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PMT Corporation, located in Chanhassen, Minnesota, is known for manufacturing and distributing high end, innovative products within the Orthopedic, Neurosurgery, and Plastic Surgery markets.  Our workplace is a community of innovators who are passionate about creating an impact.  We recognize that the collective power of our team is what propels us forward.  Together, we celebrate successes, learn from challenges, and continuously evolve in our pursuit of excellence.

Join us at PMT Corporation if you're ready to be a part of a collaborative, idea-driven, and communicative environment. Your innovation matters, and together, we can continue to shape the future of the medical device industry. 

QUALITY SPECIALIST OVERVIEW:

The Quality and Regulatory department supports the registration and compliance of PMT Corporation’s products in the U.S. and for over 100 distributors worldwide. The Quality Specialist will be responsible for ensuring that all aspects of medical device production meet regulatory standards and quality requirements.  We are looking for an individual with excellent attention to detail to join our team on-site with an 8:00am – 4:30 pm shift time.

DUTIES AND RESPONSIBILITIES OF THE QUALITY SPECIALIST (including but not limited to):

• Performing quality assurance tasks to ensure the consistent delivery of high-quality documents, services, products, and processes.
• Maintenance of FDA/MDSAP, ISO, and MDD/MDR compliance
• Work with Engineering and Quality Departments in product development to ensure compliance throughout design and manufacturing processes
• Perform product registration documentation
• Ensure Calibration and Environmental cleanroom testing is routinely completed
• Perform post-market surveillance
• Support manufacturing risk management activities
• Work directly with Internal Auditors as well as the Quality and Regulatory Affairs departments on compliance related matters
• Execute data entry and data analysis
• Aid in coordinating internal and 3^rd party audits
• Conduct complaint investigations and complete related documentation as necessary
• Engage in Corrective Action / Preventative Action (CAPA) processes as needed
• Provide support and leadership on development projects and quality issues to ensure timely submissions for market clearance
• Monitor and analyze quality data to facilitate the Site Management Review process.
• Other duties as assigned

QUALIFICATIONS OF THE QUALITY SPECIALIST:

• Bachelor’s degree in Medical Device, Engineering, or other closely related field
• Minimum 2 years of experience in Quality in the Medical Device industry
• Knowledge of Medical Device regulations such as ISO: 13485, FDA, MDSAP, and MDD/MDR
• Highly proficient attention to detail and extremely organized
• Excellent analytical skills
• Strong communication and time management skills
• Proficient in Microsoft Office Suite and Adobe
• Able to work individually and in a team setting to accomplish goals and deadlines
• Able to pass a pre-employment Background and Drug Screening  

PMT is an Equal Opportunity Employer

Location: Chanhassen, MN