Supplier Quality Auditor/Specialist

Nova Biomedical is hiring a Supplier Quality Auditor/Specialist to join Nova's Supplier Quality Engineering Team in Waltham, MA. As the Supplier Quality Auditor/Specialist you will be responsible for conducting external supplier-quality audits to ensure compliance to performance metrics and QMS requirements. As a qualified lead auditor, you will support the maintenance of the supplier audit schedule and engage with suppliers to maintain qualification and improve the overall quality performance.

More specific responsibilities will include:

• Serve as lead auditor for facility-audits (either onsite or remote) of Nova's external suppliers.
• Maintain the supplier-audit schedule and executes audits accordingly.
• Work with stakeholders and auditees to establish audit purpose and scope.
• Schedule, prepare for and coordinate assigned audits.
• Issue audit agenda, requests, and reviews pre-audit information. Conducts opening and closing meetings.
• Lead and perform both initial and surveillance audits of external suppliers.
• Write audit reports, send reports to auditee, and work with auditees to address compliance issues.
• Review, evaluate, and track audit responses; escalate overdue or unacceptable responses.
• Maintain a current working knowledge of applicable standards/requirements including ISO 13485, FDA 21 CFR820, and MDSAP.
• Support the ongoing maintenance of the Approved Suppliers List (ASL) through the following activities:
  • Onboarding of new suppliers by performing the initial evaluation.
  • Maintaining qualification-related documentation.
• Other duties as assigned, in support of Nova's mission and goals.

Qualifications:

• Bachelor's degree, preferably in a science related field, or equivalent course work with significant supplier auditing experience.
• Minimum of 5 years of quality experience in the medical device industry.
• Demonstrated experience managing supplier audits, including audit planning, audit performance, and audit reporting.
• Working knowledge of FDA cGMPs (21CFR820), ISO/EN 13485, MDSAP, and IVDR requirements.
• ASQ or other, similar auditing certification preferred.
• Skilled in the use of Microsoft Office applications and various web-browsers.
• Strong communication and interpersonal skills.
• Skilled report writer.
• Ability to travel as required. Travel anticipated up to 40% of time, with up to 10% internationally.

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 scholarship program for children of employees.