DHR Reviewer/Inspector, 1st Shift

Job Summary:

The DHR Reviewer/Inspector will be responsible for product quality assurance activities.  This includes interpretation and implementation of quality standards to routine manufacturing and product release activities.

1st Shift – Mon-Fri, 7:00am – 3:30pm

 

Essential Duties and Responsibilities:

  • Develop and maintain strong, internal working relationships across ConforMIS.
  • Understand the objectives, responsibilities, and mission of the Quality Control department and works towards those goals.
  • Prioritize and plan work activities; adapt for changing conditions.
  • Review labels for accuracy and precision.
  • Review of Device History Records to perform release of sub-assemblies and finished goods.
  • Inspect incoming, in-process, finished parts, and materials for conformance to quality control standards.
  • Trend in-process manufacturing data.
  • Implement and maintain quality system in accordance to applicable regulatory requirements.
  • Initiate and participate in resolution of non-conforming materials.
  • Responsible for final product release sign-off.
  • Develop and upgrade procedures required by the quality system as needed.
  • Other responsibilities as assigned.

Qualifications:

  • HS Diploma, Associates degree preferred or equivalent work experience.
  • 18 months or more of Quality Assurance and experience in a FDA regulated environment is preferred – with QSR (21 CFR Part 820) experience if possible.
  • Proficient in Word and Excel.
  • Thorough understanding of cGMP, GDP, ISO 13485.
  • Oracle experience a plus.

Skills, Abilities, and Competencies Required:

  • Excellent written and verbal communication skills.
  • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
  • Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness.
  • Strong organizational, analytical and time-management skills.
  • Able to self-motivate and work both independently and as part of a team.
  • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.
  • Knowledge of FDA and ISO standards for Medical Devices is a plus.
  • Ability to multi-task, perform efficiently, and independently.ConforMIS is an Equal Opportunity Employer
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