Nova Biomedical is hiring a Senior Quality Assurance Manager in our Waltham, MA headquarters. This is an opportunity for a medical device quality professional to lead a strong team with a focus on assuring company compliance to ISO/FDA QSR, IVDD, IVDR, ISO 13485 and ISO 14971. Reporting to the Director of Regulatory and Quality, this role will have direct oversight of CAPA management, ISO/QSR employee training, metrics, validation, internal and external quality auditing processes. Working onsite in Waltham, primary responsibilities include managing corporate level compliance along with day-to-day quality assurance activities at the Waltham and two Billerica manufacturing sites.
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.
Provide leadership and support during External Audits performed by regulatory bodies such as FDA and TUV, Partners and Customers, as well as other auditing bodies.
Support conducting internal audits of Nova's Quality System.
CAPA Management of internal and external CAPAs for appropriate action, risk assessment and effectivity.
Serves as Nova PLQC chair.
Management and execution of NIRs and other failure investigations.
Manage the Nova Shipping Hold processes and ensures timely interaction between functional groups.
Employee Quality Training design and delivery for companywide compliance.
Oversight of approval process for NCMRs as part of the MRB process.
Supplier Quality Engineering support for review and approval of SQE CAPA's.
Provide quality leadership of company improvement projects.
Oversee validation activities and ensure effectiveness of process.
Ensure compliance to company procedures and processes.
Quality Planning - developing and executing plans related to product development as well as new project plans.
Oversee metrics and KPI' s for evaluation and reporting at Senior Management Reviews.
Ensure timely response and feedback to Nova’s suppliers and ensure supplier-related issues are resolved in a manner that does not disrupt production processes.
Management of customer and partner qualifications, and ongoing compliance maintenance activities, such as SCARS, quality surveys and quality agreements.
Provide quality support to Nova subsidiaries
Management of documents of external origin (i.e. ISO Standards, Electrical Standards, etc.).
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 in sciences or another technical discipline, or 10-plus years of QA experience in the medical device or diagnostic industry along with 2-3 years of supervisory/management experience.
5-10+ years of medical diagnostic or device experience managing a QA program. Previous experience working directly with FDA and other auditing bodies.
Certifications are not required. However, Certified Quality Auditor and/or Certified Quality Manager through ASQ is a plus.
Internal Number: R14333
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.