Quality Assurance and Regulatory Manager/Supervisor

POSTED ON 8/25/2022 CLOSED ON 10/3/2022
ory Manager/Supervisor Hired Organization Address Alpharetta, GA Full Time

Job Posting for Quality Assurance and Regulatory Manager/Supervisor at ory Manager/Supervisor

This position is located in Alpharetta, GA.

At Pajunk Medical Systems we believe that success derives from both, high-quality and innovative products and excellent customer service. This position is an important role in a team-oriented work environment within a family owned, German medical device company. This position is full-time and depending on experience level either reports to the President of the company or the Quality System Manager. Will manage/supervise 1-2 QA associates.

Pajunk Medical Systems locally manufactures convenience kits used for regional anesthesia procedures and distributes finished products from our German mother company. The primary purpose of this position is Quality Assurance and Regulatory work. It involves 1) hands-on quality control for production 2) complaint/improvement management, and 3) regulatory affairs management, incl. required pharma and device license management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Oversee and perform routine quality control for finished products from Germany as well as raw materials, packaged kits, sterilization processing, and final product release
  • Verification, approval and documentation of custom tray requests and manufacturing
  • Write procedures/work instructions/specifications related to the quality management system
  • Perform and document cleanroom monitoring for air, product, and personnel hygiene
  • Perform and document qualification, calibration and re-certification of cleanroom and equipment
  • Participate in all processes for Operational Controls (e.g., Change Control, Design Control, Risk Management, Supplier Qualification) and Production controls (e.g., specifications, monitoring, calibrations, validations)
  • Participate in failure and improvement processes (e.g., NCRs, CAPAs, SCARs, customer complaints)
  • Track, investigate and resolve quality issues/customer complaints with production and suppliers and communicate findings with customers
  • Manage quarantine process and inventory
  • Perform FDA regulatory activities (e.g., registration/listing, Medical Device Reporting, UDI/GTIN Management)
  • Perform US state drug/device licensing activities, incl. NABP certification/audits
  • Sunshine Act Reporting and compliance/code of conduct management
  • Safety Officer: establish emergency policies and conduct related trainings
  • Other duties as required or assigned

REQUIREMENTS/EXPERIENCE:

  • Technical degree: Bachelor of Science or higher
  • 3-5 years of experience in a Quality role within an FDA regulated environment, medical devices preferred
  • Demonstrated knowledge of FDA’s 21 CFR 820
  • Experience with cleanroom manufacturing/assembly is a plus
  • Demonstrated knowledge of US state drug/device licensing requirements
  • Experience writing and following approved procedures
  • Willingness to perform routine and hands-on tasks in a small company environment
  • Ability to work independently

How to Apply: Please submit a resume and cover letter via this portal.

Due to the high volume of applications we receive, we cannot answer each application personally.

We review all incoming applications, and if we find your skills meet our particular needs, we will contact you.


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