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.

2 nd 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