DHR Reviewer/ Inspector, 2nd Shift

Job Title
DHR Reviewer/ Inspector, 2nd Shift
Job ID
27737201
Location
Wilmington,  MA 01887
Other Location
Description
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.

2nd Shift – Mon – Fri, 3:00pm – 11:30pm

Essential Duties and Responsibilities:
  • Develop and maintain strong internal working relationships across restor3d.
  • Understand the objectives, responsibilities, and mission of the Sterility & Lot Release department and work 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 finished parts, and materials for conformance to quality control standards.
  • Initiate and participate in resolution of non-conforming materials.
  • Responsible for final product release sign-off.
  • Other responsibilities as assigned.

Qualifications:
  • High School Diploma, GED, or equivalent work experience.
  • 18 months or more of Quality Assurance and experience in an FDA regulated environment is preferred – with QSR (21 CFR Part 820) experience if possible.
  • Proficient in Word and Excel.
  • Understanding of cGMP, GDP, ISO 13485.
  • Oracle experience a plus.

Skills, Abilities, 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. 
restor3d is an Equal Opportunity Employer

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