Overview
Quality Manager – Medical Device Jobs in Chanhassen, Minnesota, USA at PMT Corporation
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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.
DESCRIPTION:
PMT is hiring a Quality Manager to develop and implement quality practices where necessary. The role involves enforcing the company’s compliance with GMPs, ISO requirements, and other necessary regulations for the manufacturing of safe and effective medical devices. Responsibilities include assisting and training employees on GMPs and ensuring that empirical evidence is documented per written procedures.
RESPONSIBILITIES include but are 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 products.
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 across various departments affecting quality and regulatory requirements.
Monitors, maintains, and assists with validation, sterilization, risk management, and design activities.
Ensures that all manufacturing processes and procedures are in accordance with properly released documentation.
Assists in the resolution and documentation of product complaints.
Coordinates efforts for external services (i.e., calibration, environmental testing, and standards) according to documented schedules.
Coordinates and assists in corrective and preventative action activities and solutions.
Monitors and trends quality indicators to report to management and provide early warnings for quality-related issues.
Works with cross-functional teams to complete all assigned tasks.
REQUIREMENTS
Bachelor’s degree in a related field of engineering, science, or regulatory affairs, or equivalent experience.
Strong attention to detail.
Minimum 5 years’ experience in the medical device industry.
Experience working with quality systems, 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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Title: Quality Manager – Medical Device
Company: PMT Corporation
Location: Chanhassen, Minnesota, USA
Category: Quality Assurance – QA/QC, Healthcare
