Senior Quality Director

Senior Quality Director Department:
Quality Assurance

Location:

Waltham, MA

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Nova Biomedical:
One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

About the role

The Senior Director of Quality focuses on assuring company compliance to ISO/FDA QSR, IVDD, IVDR, ISO 13485, ISO 14971;
Direct oversight of CAPA management, ISO/QSR employee training; metrics; validation, internal and external quality auditing processes; improvements. Primary responsibilities includes managing corporate level compliance activities along with day-to-day quality activities at the global Nova Biomedical manufacturing sites. Interact directly with management at other Nova subsidiaries on issues regarding QA systems and processes.

If youre passionate about quality assurance and want to be part of a team that is shaping the future of life sciences, wed love to hear from you, apply today!

What youll do

* Provide leadership and support during external audits performed by regulatory bodies such as the FDA and TUV, Partners and Customers, as well as other auditing bodies

* Support conducting internal audits of Novas Quality System

* CAPA management of internal and external CAPAs for appropriate action, risk assessment, and effectivity

Serves as Novas PLQC chair

* Management and execution of NIRs and other failure investigations

* Manage the Nova Shipping Hold processes and ensure timely interaction between functional groups

* Employee Quality Training design and delivery for company-wide compliance

* Oversight of approval process for NCMRs as part of the MRB process

* Supplier Quality Engineering support for review and approval of SQE CAPAs

* Provide quality leadership of company improvement projects

* Oversee validation activities and ensure effectiveness of process

* Ensure compliance with company procedures and processes

* Quality Planning develop and execute plans related to product development as well as new project plans

* Oversee metrics and KPIs for evaluation and reporting at Senior Management Reviews

* Ensure timely response and feedback to Novas 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 Novas subsidiaries

* Management of documents of external origin (i.e. ISO Standards, Electrical Standards, etc.)

What we are looking for in you

* Certifications are not required. However, Certified Quality Auditor and/or Certified Quality Manager through ASQ is a plus

* Strength in organizational skills

* Proven track record with process improvements

* Communication with various functional departments will be critical to achieving successful outcomes

* Strong communication and presentation skills

* Working knowledge of GMP is required

* Demonstrated ability to provide Root Cause Analysis tools and structured problem-solving methodologies to QMS issues

* Skilled at performing and leading internal and external audits

* Technical knowledge of Nova-type products is a plus

* Knowledge of LMS software

* 12+ years of medical diagnostic or device experience managing a quality program

* 12+ years of quality team management

* BS Degree in the sciences or other technical discipline, or 10+ years of QA experience in the medical device or diagnostic industry

Physical Requirements for this role include:

* Ability to work at a computer for extended periods.

* Ability to lift and carry up to [2550] pounds as required

* Ability to communicate effectively via phone, video, and written communication.

* Ability to occasionally move about the office to access meetings or resources.

Why work for Nova Biomedical

* Flexible Medical, Dental, & Vision Coverage

* Competitive 401k company…