Quality Associate – Quality and Regulatory

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. As a Quality Associate, a majority of your day will be executing quality inspections to ensure the safety and reliability of Pajunk products are in compliance with quality and regulatory requirements.

The purpose of the position is to maintain quality standards by approving incoming materials, in-process production, and finished products, and recording quality inspection results. The Quality Associate is also responsible for maintaining, and distributing controlled documents and records related to the Pajunk Quality Management System. This position requires excellent organizational skills and attention to detail as it relates to critical aspects of the Quality System.

This position is an important role in a team-oriented work environment within a family owned, German medical device company.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Quality Associate Duties & Responsibilities –

  • Perform inspections of the quality attributes of Pajunk products according to written Standard Operational Procedures (SOP’s) and Work Instructions (WI’s).
  • Comply with all company policies, procedures, work instructions and training requirements.
  • Perform inspection of incoming raw materials according to established specifications. Tag all non-conforming material and place in quarantine.
  • Perform in-process inspections and labeling and packaging inspections of Pajunk convenience trays as specified in the appropriate SOP’s and work instructions.
  • Inspection of all returned product to ensure product quality is not compromised and the product is in good, re-sellable condition.
  • Interact with production and warehouse personnel to ensure quality, packaging, and documentation requirements are met.
  • Escalate issues to Quality and Regulatory Manager.
  • Maintain, control, and distribute controlled documents and records related to the Pajunk Quality Management System.
  • Assist with monthly and quarterly monitoring of cleanroom and warehouse.
  • Document and maintain records of all quality activities as required by the Pajunk Quality Management System.
  • Perform other related duties as assigned.

QUALIFICATIONS:

  • High School Diploma or GED equivalent.
  • At least 1-2 years manufacturing or quality related experience.
  • Prior experience working in an FDA regulated environment preferred.
  • Demonstrates organizational skills and is very detail oriented.
  • Basic computer skills (MS Word, MS Excel, MS Outlook).
  • Ability to stand for extended periods of time
  • Ability to occasionally lift and/or move up to 50 pounds
  • A current US work authorization is required