DHR Reviewer/Inspector, 2nd Shift
- Job Title
- DHR Reviewer/Inspector, 2nd Shift
- Job ID
- 27738358
- Location
- Wilmington, MA, 01887
- Other Location
- Description
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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
