Quality Manager - Medical Device

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.

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:

• Becomes personally skilled in all inspection and testing procedures.

• Coordinates and conducts quality audits per the defined schedule.

• Develops procedures and SOPs to control inspected and non-inspected product.

• Assists in the development, maintenance and implementation of processes and procedures in accordance with regulatory requirements.

• 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.

• Establishes that all manufacturing processes and procedures are in accordance with properly released documentation.

• To assist in the resolution, documentation, customer responses of product complaints.

• Coordinate efforts for external services (i.e. calibration, environmental testing, and standards) to perform tasks according to documented schedules.

• Coordinate and assist in corrective and preventative action activities and solutions

• Monitor and trend quality indicators to report to management and to provide early warning for quality related issuesall 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, or equivalent experience.

• Strong attention to detail.

• Minimum 5 years' experience in medical device industry.

• Experience working with quality system, ISO and quality assurance.

• Excellent communication and time management skills.

• Proficient in Microsoft Office Suite.

Location: Chanhassen, MN

PMT is an Equal Opportunity Employer

JOB CODE: QMJun2024

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…","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.

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:

• Becomes personally skilled in all inspection and testing procedures.

• Coordinates and conducts quality audits per the defined schedule.

• Develops procedures and SOPs to control inspected and non-inspected product.

• Assists in the development, maintenance and implementation of processes and procedures in accordance with regulatory requirements.

• 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.

• Establishes that all manufacturing processes and procedures are in accordance with properly released documentation.

• To assist in the resolution, documentation, customer responses of product complaints.

• Coordinate efforts for external services (i.e. calibration, environmental testing, and standards) to perform tasks according to documented schedules.

• Coordinate and assist in corrective and preventative action activities and solutions

• Monitor and trend quality indicators to report to management and to provide early warning for quality related issuesall 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, or equivalent experience.

• Strong attention to detail.

• Minimum 5 years' experience in medical device industry.

• Experience working with quality system, ISO and quality assurance.

• Excellent communication and time management skills.

• Proficient in Microsoft Office Suite.

Location: Chanhassen, MN

PMT is an Equal Opportunity Employer

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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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