Director Instrument Quality Management
Director of Instrument Quality Management is responsible for all aspects of quality assurance and quality engineering for Instrument will oversee the entire instrument life-cycle including product development and manufacturing as well as responsibilities for management of the OEM instruments and system integration for the DS Business Unit.
This role will have the responsibility for the development and implementation of design and manufacturing control processes required for the development and manufacturing of Class I through III instruments.
The role will have direct reports in US, Holland and dotted line reports in China (Suzhou 2) plants as well as the oversight of the instrument development activities at Baltimore, Holland and San Diego design centers as well as the OEM produced and developed instruments.
An individual in this position will have the responsibility of development and execution of an Instrument Quality Strategy and goals linked to the Diagnostic Systems Business Unit and WW Quality Strategy.
This position will have an oversight of new product development quality assurance, sustaining quality engineering, continuous improvement of quality processes and will have an oversight of multiple manufacturing plants producing BD DS Instruments.
Director of Instrument Quality Management will report directly to Vice President of Quality Management.
Key Responsibilities for this Role:
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- Develop and execute quality strategy for instrument design and manufacturing and establish goals for the quality organization.
- Ensure effective execution of the quality engineering activities in support of new product development and sustaining engineering projects.
- Lead, develop, engage and mentor quality organization.
- Continuously improve quality processes and quality system with the goal of improving regulatory compliance, product quality, cost and customer satisfaction.
- Execute design transfer and product transfer activities among DS manufacturing plants.
- Proactively manage quality of the OEM, component and subassembly suppliers.
- Ensure effective and compliant quality operation for quality engineering, CAPA, non-conformance, customer complaint investigation, engineering change management, and other relevant aspects of the quality system.
- Lead implementation and utilization of quality tools such as six sigma, risk management, SPC, root cause analysis, and DOE.
Key Qualifications and Attributes:
- Director of Instrument Quality Management should possess strong knowledge of WW medical device regulations and quality sciences with specific focus on Class III design and manufacturing. An In-Vitro-Diagnostic Knowledge is highly desired.
- An individual in this role must have excellent leadership, communication, organization and project management skills.
- Strong knowledge of design controls and risk management is required.
- Excellent knowledge of quality engineering sciences.
- Strong knowledge of software quality and reliability engineering is desired.
- Experience as an interface in regulatory compliance audits such as the FDA, ISO, PAL, Anvisa and others.
- A minimum of 10 years of quality assurance or relevant experience. A minimum of 5 years of quality leadership or relevant experience. Experience should be in the Medical Device or Diagnostic industry.
- Bachelor of Science in Engineering, Science (Chemistry, Physics, etc.), or other Technical Discipline. Master of Science in Engineering, Science, Business Administration is desired.
- The ability to make timely critical decisions regarding product quality and/or quality system compliance.
- The ability to effectively lead teams and influence.
- An expert understanding of quality engineering sciences.
- A thorough understanding of 21 CFR §820, ISO 13485, and ISO 14971.
- The ability to prepare, and understand technical documentation such as Engineering Drawings, Operating Procedures, Work Instructions, Technical/Validation Studies, etc.
- The ability to assess and articulate risk when evaluating a situation.
- The ability to perform thorough investigations, identify the root cause(s) of an issue, and propose appropriate corrective action(s).
- The ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone or in teams.