Director of Global Quality and Regulatory

1 week ago

Greater Toronto Area Canada, Ontario The Mullings Group Full time

About the Role: Leads the Quality and Regulatory of Contract Manufacturing at Sterling by driving the Customer, Internal, and Supplier Quality process and results through the quality system. Provides leadership and direction to the company’s quality team to ensure the achievement of business goals and objectives by ensuring the distribution of quality products and compliance with all applicable local, state, and federal agencies and regulatory bodies. Also accountable for ensuring cross-functional alignment and support where needed to meet ISO quality standards and regulatory compliance requirements.



Responsibilities:


  • Leads the Quality of Contract Manufacturing at Sterling by driving the Customer, Internal, and Supplier Quality process and results through the quality system
  • Supports new business opportunities and acquisitions by working with Customer and site leaders to develop best practices within our business to ensure compliance and drive revenue through improved customer experience
  • Responsible for the implementation and compliance with Quality agreements for the Customer and Suppliers
  • Responsible for the selection, supervision, development, and objective setting for teams consisting of managers, individual contributors, and clerical/technical staff
  • Develops, leads, and executes a Quality Strategy, ensuring that the Quality Strategy is appropriate and effective in meeting the business needs
  • Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people
  • Directs all quality activities to ensure new customer product implementation and product sustainment meet regulatory requirements and customer quality expectations
  • Establishes global standards for customer product design and sustainment supported by our Quality teams
  • Oversees participation in the reviewing of customer designs to ensure consideration for and compliance to Quality Assurance requirements and considerations
  • Works with other senior leaders within the business to align quality system objectives within their teams
  • Partners with quality leaders from other sites to develop quality policies and procedures in support of site and corporate quality needs
  • Participates in Sales meetings and Customer site visits as appropriate
  • Assures that the requirements of 21 CFR Part 820, ISO13485, ISO 14971, and any other applicable government or international standards are implemented and maintained
  • Oversees the documentation required to meet regulatory requirements for all aspects of the QSR and international governing bodies
  • Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal procedures to assure compliance and then assists the organization in driving implementation


Qualifications:


  • Quality Management in contract manufacturing of medical devices
  • Experience in a quality function leadership role within the medical device industry, working under ISO 13485, FDA, and Health Canada Quality System regulations with Class 2 medical devices as a minimum
  • Minimum of seven years experience in a quality management or similar leadership role, leading and mentoring employees
  • QMS success across multiple sites/locations, including implementation of new programs and systems (ie. QMS, EDHR)
  • Bachelor’s degree or above in science, engineering, or quality
  • Quality assurance educational courses, programs, or certificates, and Lead Auditor certification are preferred
  • Ability to solve complex problems, including identification of strengths/weaknesses, locating alternative solutions and conclusions, and approaches to problems
  • Ability to effectively influence others in a matrixed organization
  • Ability to listen and communicate effectively using verbal and written communication methods, including presenting ideas to executive leadership
  • Advanced knowledge of quality management methods, tools, and techniques used to create and support an environment that meets the needs of the organization

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