As a quality professional in the medical device industry in the Boston area, we know that you have a vast number of opportunities. What makes this one unique? Our company is transitioning from R&D to building and launching a product. This is a entry level career opportunity for a quality engineer to partner with manufacturing operations, be a part of quality projects, and learn and grow with our company.
Sanvita Medical, an exciting new medical device company in diabetes healthcare operating within one of Nova Biomedical?s facilities, is hiring a Quality Engineer. Reporting to the Quality System Manager, in this role, you will focus on assuring company compliance to FDA QSR, ISO 13485, and ISO14971, as well as additional regulatory requirements with a principal focus on suppliers and manufacturing.
Supporting the pending commercialization of a new and innovative medical device, your responsibilities will include development of metrics for all areas of the supplier, incoming (MRB and NCMRs), and manufacturing quality and report metric results at Product Reviews.
- Device History Record (DHR) review to ensure compliance with company procedures, ISO standards, and QSR Regulations.
- Facilitator for material and product nonconformance (NCR) resolution from Incoming Inspection and Manufacturing (MRB).
- EO Sterilization review and release.
- Product acceptance testing and release.
- Help develop and maintain Quality Control procedures and methods.
- Assist Engineering and Manufacturing on equipment and process validations (IQ, OQ, PQ).
- Coordinate/manage equipment calibration with outside service providers.
- Monitoring of ISO Class 7 cleanrooms.
- Collect and compile Incoming, product, and manufacturing data for analysis
- Other additional responsibilities as deemed by management to support the Sanvita Quality Assurance and Regulatory requirements.
- 0-2 years experience in Quality Assurance, Quality Control, or Manufacturing.
- Previous experience working in a FDA, or other regulated industry a plus.
- Previous experience with medical product manufacturing or testing is a plus.
- Incoming Inspection support experience a plus.
- Cleanroom experience a plus
At Nova Biomedical, we practice our core values of mutual respect, honesty, and integrity throughout the company. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years.
Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria and an innovative
How To Apply
Please email your resume to email@example.com for consideration