Job Title

About Sterling IndustriesEstablished in 1984, Sterling Industries provides end-to-end Contract Manufacturing of medicaldevices and components to Fortune 100 OEMs, as well as mid-size medical device OEMs andfast-growing scale-ups. Registered with the U.S. FDA and Health Canada, Sterling helps clientsdeliver successful ISO 13485 Quality products through its vertical integration. It manages theentire 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 RoleLeads the Quality of Contract Manufacturing at Sterling by driving the Customer, Internal, andSupplier Quality process and results through the quality system. Provides leadership anddirection to the companys quality team to ensure the achievement of business goals andobjectives by ensuring the distribution of quality products, as well as compliance with allapplicable local, state, and federal agencies and regulatory bodies. Also accountable forensuring cross-functional alignment and support where needed to meet ISO quality standardsand 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 siteleaders to develop best practices within our business to ensure compliance and drive revenuethrough improved customer experience. Provides leadership for the companys quality organization. Responsible for the implementation and compliance with Quality agreements for the Customerand Suppliers Responsible for the selection, supervision, development, and objective setting for teamsconsisting of managers, individual contributors, and clerical/technical staff. Develops, leads, and executes a Quality Strategy, ensuring that the Quality Strategy isappropriate and effective in meeting the business needs. Participates in the corporate development of methods, techniques, and evaluation criteria forprojects, programs, and people Directs all quality activities to ensure new customer product implementation and productSustainment meets regulatory requirements and customer quality expectations. Establishes global standards for customer product design and sustainment, supported by ourQuality teams. Oversees participation in the reviewing of customer designs to ensure consideration for andcompliance with Quality Assurance requirements and considerations. Works with other senior leaders within the business to align quality system objectives withintheir 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 otherApplicable government or international standards are implemented and maintained. Oversees the documentation required to meet regulatory requirements for all aspects of theQSR 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 drivingimplementation. Defines, specifies, and/or approves of the implementation of standards, methods, andprocedures for inspecting, testing, and evaluating the precision, accuracy, and reliability ofCustomer 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 systemRequirements 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 anddevelopment by fostering personal growth, being responsible and accountable, and beingpassionate towards the success of the business, and treating all with dignity and respect. Responsible for the Quality teams budget.Position Requirements: Quality Management in contract manufacturing of medical devices Experience in a quality function leadership role within the medical device industry, workingunder ISO 13485, FDA, and Health Canada Quality System regulations with Class 2 medicaldevices as a minimum Minimum of seven years of experience in a quality management or similar leadership role, leadingand mentoring employees. QMS success across multiple sites/locations, including implementation of new programs andsystems ( ie. QMS, EDHR ) Bachelors degree or above in science, engineering, or quality. Quality assurance educational courses, programs, or certificates, Lead Auditor certificationpreferred. Ability to solve complex problems, including identification of strengths/weaknesses, locatingalternative 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.