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Director, Quality - New Product Development

Job Description SummaryIn general, the Director, Quality ? New Product Development is responsible for quality design assurance activities for Instruments and Reagents within the Global Product Development System (GPDS). This role will have the responsibility for the development and implementation of design control processes and quality assurance processes required for the development of Class I through III instruments and reagents.
The role will have direct reports in US as well as the oversight of the development activities at Baltimore, The Netherlands and San Diego design centers as well as the OEM produced and developed instruments and reagents.
This position will have oversight of new product development quality assurance and the continuous improvement of quality processes related to New Product Development activities.
This role will have a direct oversight of the large and very complex organization in support of instrument and reagent development. This role will interact with senior business and quality leaders throughout the DS and WW BDX regional organizations with the goal to ensure that customer expectations are met and that instruments and reagents are designed and developed with the highest reliability and quality. This role will have direct influence over quality improvements for instruments and reagents in the field and timely resolution of quality / design issues.
The Director, Quality ? New Product Development will report directly to Vice President of Quality Management.
Job Description
Key Responsibilities for this Role:
Develop and execute quality strategy for instrument and reagent design and establish goals for the quality organization.
Ensure effective execution of the quality engineering activities in support of new product development.
Lead, develop, engage and mentor quality design assurance organization.
Continuously improve quality processes and quality system with the goal of improving product quality, cost and customer satisfaction through implementation of DFSS, DFM, Risk Management and Reliability Engineering best practices.
Execute design transfer activities among DS manufacturing plants.
Ensure effective and compliant quality operation for engineering change management, and other relevant aspects of the quality system as it relates to New Product Development activities.
Lead implementation and utilization of quality tools such as six sigma, risk management, root cause analysis, and DOE.
Key Qualifications and Attributes:
Director, Quality ? New Product Development should possess strong knowledge of WW medical device regulations and quality sciences with specific focus on Class III design. 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.
Professional certification is an advantage (i.e, CQA, CQE, SQE, CQM, Etc)
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, Quality System Procedures, 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.
Primary Work LocationUSA MD - Baltimore
Additional Locations
Work Shift



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