Quality Engineer Med Device Entry Level

1 week ago

Chanhassen, United States PMT Corporation Full time

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 PROCESS ENGINEER OVERVIEW:

PMT Corporation is hiring a Quality Process Engineer to develop and implement quality practices where necessary. The Quality Process Engineer will enforce company’s compliance to the GMPs, ISO requirements and other requirements necessary of a medical device manufacture of safe and effective devices. They will assist and train employees where necessary on the GMPs and follow the established system. The Quality Process Engineer will also apply efficient technical solutions and ensure empirical evidence is documented per written procedures.

RESPONSIBILITIES OF THE QUALITY PROCESS ENGINEER (include but not limited to):

  • Able to perform inspection and testing procedures, as needed.
  • Coordinates and manages internal quality audits, per the defined schedule.
  • Directly involved with onsite regulatory audits with the FDA inspectors and / or Notified Body auditors.
  • Reviews and approves procedures to control inspected product and materials.
  • Assists in the development, maintenance and implementation of processes and procedures in accordance with regulatory requirements.
  • Manages calibration activities and cleanroom environmental testing.
  • Completes risk assessments of equipment found out of calibration.
  • Monitors, maintains and assists with validation, sterilization, risk management and process improvement activities.
  • Establishes that all manufacturing processes and procedures are in accordance with properly released documentation.
  • Completes GAP analysis of updates to regulatory standards.
  • Assists in the resolution and documentation of customer complaints.
  • Coordinates and assists in corrective and preventative action activities and solutions.
  • Completes trend analysis and monitors quality indicators to report to Management, as well as provide early warning for quality related issues to all employees throughout all departments.
  • Works with cross-functional teams to complete all assigned tasks.

QUALIFICATIONS:

  • Bachelor’s degree in related field of engineering, science, or regulatory affairs.
  • Minimum 1-2 years of experience, preferably medical devices.
  • Strong attention to detail and highly organized.
  • Experience working with quality systems, ISO, and quality assurance.
  • Excellent communication and time management skills.
  • Proficient in Microsoft Office Suite.
  • Ability to pass a Background Check and Drug Screening.

Location: Chanhassen, MN

PMT is an Equal Opportunity Employer

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