Nova Biomedical is hiring a Senior Quality Assurance Specialist in our Waltham, MA headquarters. This is an opportunity for an experienced quality professional to take on a new challenge with a growing medical device company. We are seeking a candidate with strength in any combination of the following: driving QMS continuous improvement projects, working with document control processes, and ensuring proper root cause analysis through CAPA.
Nova Biomedical is a company dedicated to using advanced technology to develop better blood testing analyzers for medical use. Nova is the largest privately owned IVD company in the U.S. with over 1,200 employees globally.
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.
As a Senior Quality Assurance Specialist, you will support activities within the corporate Quality Management System (QMS) and Good Manufacturing Practices (GMPs).
Maintain and Improve the Quality System to ensure compliance with ISO standards, QSR and MDSAP Regulations
Provide external audit support during regulatory body inspections by interfacing directly with FDA, TUV, partners, customers
Participate in Internal Quality Audit program, including interfacing with Nova’s international subsidiaries
Responsible for CAPA and NRA activities, including facilitating timely response and QMS metrics
Apply accepted risk management principles to make decisions related to Nova Biomedical’s processes and products.
Review, approve, and be able to explain impact of NCMRs as part of the MRB process
Review, approve, and determine impact of ECOs and MVs on the product development and manufacturing process
Develop and execute new Quality Project Plans to improve QMS; coordinate an analysis of QMS metrics
Initiate, revise and review controlled GMP documentation including procedures.
Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, delicious and company subsidized cafeteria and an innovative scholarship program for children of employees.
Bachelor's degree (or equivalent experience) in Life Sciences or another STEM field
5+ years of experience in quality assurance, including working in medical device industry
Additional hands-on experience working in laboratory or R&D is helpful
Knowledge of FDA QSR, MDSAP, ISO 13485, and ISO 14971 (IVDD, IVDR, or MDR is also a plus, but not required)
Previous experience with performing internal audits and supporting external audits with FDA and other auditing bodies.
About Nova Biomedical
Nova Biomedical develops, manufactures, and sells advanced technology blood testing analyzers. We employ over 1,200 people, with sales and service subsidiaries in eight countries and distributors in more than 91 additional countries. Nova has manufacturing facilities in Waltham and Billerica, Massachusetts; and Taipei, Taiwan. Nova is one of the 25 largest in vitro diagnostic companies in the world and the largest privately owned in vitro diagnostic company in the United States.