Quality Assurance Engineer II

Job Order #: 15835606

Billerica, MA 01821

Full Time

40 hours per week

POSTED 11/17/2021

EXPIRES 2/15/2022

Job Description

MassHire Lowell Career Center is working with a well-known company in the Billerica, MA area who is looking for a Quality Assurance Engineer II. The company is dedicated to using advanced technology to develop better blood testing analyzers for medical use. They are the largest privately owned IVD company in the U.S. with over 1,200 employees globally.    

Highlights of benefits to employees includes
- Blue Cross Blue Shield medical plan
- Tuition reimbursement
- Matching 401(k)
- An innovative scholarship program for children of employees.

Quality Assurance Engineer II

Responsibilities: Maintains and improves the Supplier Quality Management System to ensure compliance with ISO standards, QSR Regulations and other regulatory requirements and standards. Facilitator for material and product nonconformance (NCMR) resolution. Assists Engineering and Manufacturing with supplier issues and supplier Corrective Actions. Develop and maintain production Quality Control procedures and methods and train QC personnel. Work with Engineering and Manufacturing on equipment and process validations and process FMEA's. Provide audit support during regulatory body inspections with FDA, TUV, and partners. Assist in the qualification, validation, and continued monitoring of ISO Class 7 Clean Rooms. Conduct internal audits of Sanvita's Quality System and critical/key supplier audits. Facilitate and manage equipment calibration using an outside supplier. Assist in the training of Sanvita personnel on the Quality System and help maintain the training system. Collaborate with department/system SME's to develop and/or revise existing procedures (OPs, OIs, work instructions) to ensure documentation is compliant to the Internal Quality System and external regulatory requirements. Facilitate product complaint investigation in coordination with product development and manufacturing. Other additional responsibilities as deemed by management to support the Sanvita Quality Assurance and Regulatory requirements.

- BS Degree in Life Sciences, Engineering, or related discipline.
- MS degree a plus.
- Strong writing, communication, leadership, and presentation skills.
- Ability to work with minimal supervision with a small team.
- Experience in a diabetes related industry is a plus. Six Sigma Green or Black Belt is a plus.
- ISO 13485 Lead Auditor experience is a plus.
- A minimum of 3 years medical device experience in Quality Assurance, or Quality Control.
- Previous experience working in an FDA, and/or notified body regulated company.
- Previous experience with implantable medical devices is a plus.
- Manufacturing engineering experience a plus. Clean Room experience a plus.

Please email your resume to thavrith.thao@masshirelowellcc.com for consideration

How To Apply

Please email your resume to thavrith.thao@masshirelowellcc.com for consideration


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Thavrith Thao


Bussiness Service Representitive






107 Merrimack Street
Lowell, MA 01852