Reporting to the Associate Director, Unit Quality WW IPD, the Senior Manager - Quality Engineering provides direct management and technical support to the Quality Engineers supporting the WW IPD Design Center. The position shall provide quality engineering leadership, oversight, and direction in problem-solving and team-building capabilities. The position is also responsible for sustaining a QMS that complies with applicable standards and regulations, consistent with Corporate and Business Unit policies and procedures. The position shall support new product development and product maintenance through the application of Quality engineering skills for medical devices, assuring that all BD products are designed utilizing systems which comply with applicable regulatory standards and conform to customer expectations for safety and effectiveness.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Responsibilities
Responsible for Design Center Quality deliverables associated with Gravity and Dedicated Sets:
Lead execution of Unit Quality activities required to meet Business Driver Goals (BDGs), Key Driver Goals (KDGs), and quality metric targets for product platforms and/or processes responsible for as established by the Unit Quality Associate Director, WWIPD.
Resolution of Quality issues (CAPA, SA, AIs, advanced complaints, etc.)
Product expert that ensures customer requirements are met.
Liaises with other functions, such as PMQ, Supplier Quality, Plant Quality, etc. to resolve Quality and Compliance matters.
Lead a team of Unit Quality engineers to support business needs, including compliance risk remediation, new product development, and cost reduction efforts linked to operational effectiveness.
Assumes a leadership role in continuous improvement and development of strategies to improve Quality.
Establish and maintain a team structure that provides excellent customer service and enables optimal use of resources.
Provide required input for IPD Management Review.
Support Quality Management System maintenance and improvement activities.
Implement, measure and report on the progress of the Quality Management critical initiatives.
Assure that the policies, procedures, and systems are designed and implemented to develop products which conform to established quality standards and comply with Industry and Government Standards.
Provide the required Quality Engineering support and promote use of statistical tools in product design and development activities.
Support manufacturing sites, including change control process support, with appropriate technological and problem-solving skills and resources to prevent and or minimize adverse situations.
Lead Risk Management activities for products under design authority in compliance with ISO 14971.
Develop and continuously improve skills and adequacy of department resources in order to maintain appropriate levels of Quality Assurance.
Develop and apply innovative approaches within the Quality Assurance function.
Provide support/ mentoring/ coaching of QEs for application of technical principles, theories, concepts and quality, tools and systems; develop personnel, including dedicated succession planning and contingency management focused on win-win situations.
Develops technical solutions to complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity.
Provide feedback to prepare budget and adhere to approved departmental budget.
Scope of Responsibilities
Leads a team of Quality Engineers at the design center. Performs functional activities without appreciable direction.
Assignments are often self-initiated. Determine and pursue course of action necessary to obtain desired results.
Plans and participates in subject areas strategically relevant to the business and/ or functions.
Participates in, and may provide leadership for multi-disciplinary projects
Perceived as a thoughtful Leader and considered Site/ functional level Subject Matter Expert.
Required Qualifications:
Bachelor's degree in Engineering, Master's preferred
Fifteen years of proven experience in quality design and technical knowledge
Five years of people management experience
Experience in medical device industry
Experience working in a design center
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
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, or any other protected status.
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Primary Work Location
USA CA - Brea
Additional Locations
USA CA - San Diego TC Bldg C&D
Work Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
