The Mullings Group
About Sterling Industries
Established in 1984, Sterling Industries provides end-to-end Contract Manufacturing of medical
devices and components to Fortune 100 OEMs, as well as mid-size medical device OEMs and
fast-growing “scale-ups”. Registered with the U.S.
FDA and Health Canada, Sterling helps clients
deliver successful ISO 13485 Quality products through its vertical integration. It manages the
entire process, including the supply chain, manufacturing, assembly, testing, labeling,
packaging, and shipping.
The company operates from facilities in suburban Toronto and Kalamazoo, Michigan.
About the Role
Leads the Quality 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, as well as 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. The role reports to the Chief Executive Officer (CEO).
Key Responsibilities include:
• 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 the Customer and the site
leaders to develop best practices within our business to ensure compliance and drive revenue
through improved customer experience.
• Provides leadership for the company’s quality organization.
• 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 the 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 meets 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 with 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.
• Defines, specifies, and/or approves of the implementation of standards, methods, and
procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of
Customer products.
• Reviews and approves new and changed quality system documentation for product and process development.
• Responsible for ongoing Nonconformance and CAPA executive oversight.
• Leads and participates in all internal and external audit activities
• Regularly communicates and drives the overall RA/QA vision, quality goals, and achievements to all employees as well as to executive staff.
• Leads and ensures that training of company employees on the Quality Management system
Requirements are current, and there is ongoing action for competence and skill excellence.
• Supports the growth and development of the team by investing in employee involvement and
development by fostering personal growth, being responsible and accountable, and being
passionate towards the success of the business, and treating all with dignity and respect.
• Responsible for the Quality team’s budget.
Position Requirements:
• 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 of 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, Lead Auditor certification
preferred.
• Ability to solve complex problems, including identification of strengths/weaknesses, locating
alternative solutions, 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
• Ability to manage multiple concurrent objectives, projects, groups, or activities, making effective judgments as to prioritizing and time allocation.
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