BD (Becton, Dickinson and Company) Senior Quality Manager in San Jose, California
Job Description SummaryThe Sr. Quality Manager is responsible for quality design assurance activities for Instruments and Reagents within the Global Product Development System (GPDS) supporting quality assurance for New Product Development at BDB. The Sr. Quality Manager has responsibility for the Quality New Product Development team and will ensure that all projects are completed within schedule, on budget, appropriately resourced, and that the instruments and reagents are designed and developed with the highest reliability and quality. This person will handle projects and tasks, from product inception through product launch and maintenance. This person will play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. Successful performance requires close collaboration with quality management, operations, suppliers and/or BD associates to assure compliance with ISO, FDA, and BD quality policies, procedures, and practices.
This position will have oversight of new product development quality assurance and the continuous improvement of quality processes related to New Product Development activities. The incumbent will be expected to be the Subject Matter Expert and will be responsible for making decisions and recommendations that will result in the achievement of goals critical to organizational objectives. This may require the ability to implement and communicate the strategic and technical direction for the product/project team. The successful candidate will be able to proactively identify issues that may delay product or project and recommend appropriate actions to remedy. The incumbent will be expected to work under consultative direction toward predetermined long-range goals and objectives.
Strong knowledge of Design Controls and risk management
A thorough understanding of 21 CFR §820, ISO 13485, ISO 9001 and ISO 14971.
Ability and skill to effectively manage multiple tasks and drive execution of organizational objectives and strategies
Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and senior management/executive level
Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution
Ability to manage budgets, work schedules and performance requirements
The ability to effectively lead teams and influence.
Bachelor of Science (BSc) or Engineering (B.Eng.) or related field required
Minimum 5-8 years experience in Quality, Regulatory, or Operations of a Medical Device firm
Professional certification preferred (i.e, CQA, CQE, SQE, CQM, Etc)
Extensive knowledge and experience of applicable regulatory and FDA medical device requirements.
Primary Work LocationUSA CA - San Jose
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status