Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Director of Capital Equipment Quality Systems
Description
General Summary:
Act as the Corporate Steward of the capital equipment Quality System. Lead the development, establishment and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of capital equipment conform to established standards and agency guidelines. Ensures capital equipment elements of the Corporate Quality System are compliant with all relevant regulatory requirements. Collaborate with a variety of stakeholders and users of the quality systems to facilitate continuous improvement of associated capital equipment policies, standards, SOP’s and tools. Assist the rest of the organization in the implementation of these continuous improvement efforts.
Occasionally, serve as liaison between the company and the various governmental agencies.
Duties and Responsibilities:
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Develops, establishes and monitors quality assurance systems, policies, processes, procedures and controls ensuring that performance and quality of capital equipment conforms to established company, international (ISO), and governmental regulatory standards and agency guidelines.
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Facilitate the creation and champions improvement in capital equipment quality systems including, but not limited to, configuration management, new product development, product life cycles (end of life), reliability metrics, software validation/control, post market compliance, complaints definition, recall management, labeling and distribution.
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Supports and leads the Management Review process of metrics measuring the capital equipment quality system.
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Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance, and then assist the organization in driving implementation
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Encourages problem-solving processes leading to solutions for leverage across divisions, regions and individual sites. Ensure sharing of initiatives/ideas and accomplishments across these same groups.
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Leads technology advancements for the department, and develops and ensures budgets and schedules meet corporate requirement. This includes analyzing current SAP functionality for it’s suitability for capital equipment and making recommendations for changes.
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Keeps current on changes to all regulatory requirements and facilitates implementation into the Boston Scientific systems.
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Collaborates with multiple cross-functional colleagues to ensure achievement of standards and regulations during capital equipment new product development and commercialization activities.
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Coaches, develops and mentors Quality employees. Allocates/re-allocates internal and external resources, as needed
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Responsible for succession planning and the development and implementation of retention strategies of staff. Ensure implementation of functional excellence initiatives.
Minimum Education & Experience:
Candidate possesses a B.S. Degree with a 10-14 years experience in quality and regulatory for capital equipment medical devices. 7-10 years of supervisory experience recommended. The majority of experience should be in capital equipment medical devices. An advanced engineering degree or MBA is highly desirable.
Good grasp of FDA protocol and process as well as other international regulations governing the medical device industry
Working Conditions:
General office environment, with potential (domestic and international) travel to BSC facilities for audits and other meetings
Competency Expectations:
Demonstrated success in creating a strategies to lead a team to success
Must be thoroughly familiar with the FDA and CE Marking and the Boston Scientific quality requirements associated with developing products in a regulated industry
Broad understanding US and International regulations including 21 CFR, 820, 210, 211, and 11 is required.
Considerable personal experience presenting, interacting, and building effective relationships with regulatory agencies
Excellent communication and presentation skills (articulate and persuasive)
Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with medical professionals
Teaches and coaches others in technical and leadership areas.
