Quality Specialist

Find Fulfillment in Work Every Day! We Offer Careers that Make a Difference.

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

• 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 3rd 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

JOB CODE: QSMarch24

Find Fulfillment in Work Every Day! We Offer Careers that Make a Difference. 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…","html_description":"

Find Fulfillment in Work Every Day! We Offer Careers that Make a Difference.

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

• 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 3rd 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

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I certify that all information submitted by me on this application is true and complete to the best of my knowledge. I understand that if employed, false statements or omissions on this application shall be considered cause for dismissal. I authorize the Company to conduct a thorough background investigation of my work and personal history, and to verify all data given on this application and during interviews. I authorize all individuals, schools, and firms named to provide any requested information and release them from all liability for providing the requested information.
I understand that nothing contained in this employment application, or in the granting of an interview, and no Company policies, procedures, or manual that I might receive are intended to create an employment contract between the Company and me. If an employment relationship is established in writing, I understand that this employment relationship is "at-will" and that I have a right to terminate my employment at any time for any or no reason, with or without cause and with or without prior notice, and the Company retains a similar right.
I understand the Company may require the successful completion of a drug and/or background check as a condition of employment.

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