Job Description Summary

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 makerof possible with us.

This role will lead the Product Quality and Communications (PQC) team, which is responsible for 1) the creation and management of communications with FDA and other regulatory agencies, 2) ensuring that commitments made to the FDA and other regulatory agencies (e.g., recall letters) are implemented at the business unit; these may include improvements to processes or products; and 3) approach and processes for CAPA initiation determination, Situation Analyses and escalation to Field Action Committee decisions are consistently applied across the MMS BU.  This team will bring strong quality systems, technical, and project management experience to be able to align information from cross-functional areas within the business unit with expectations from external regulatory contacts.  Activities include:

• Facilitates the collection of information and technical writing of communications with FDA and other regulatory agencies, including periodic reports for responses to audits and inspections, enhanced post-market surveillance reports, field remediation reports, “Additional Information Requests” related to inquiries about adverse events, device malfunctions, or recalls, and other communications

• Facilitates the implementation of commitments made to FDA and other regulatory agencies, including end-to-end process improvements, procedural updates, design/manufacturing/labeling changes, etc.

• Coordinates and facilitates a unified approach and process for CAPA initiation determination processes leading to the creation of CAPAs, product investigations (SAs) and escalation to Field Action decision, as applicable.

• Collaborates with leadership in Business Unit Quality, Regulatory Affairs, R&D, Operations, Service, Medical Affairs, Legal, Regional Compliance, and Post Market Quality on the review and approval of the communications

• Actively participates in inspections and audits at the San Diego, Tijuana, and other sites as required, including pre-inspection activities, inspection management, responses, and remediation

• Actively participates in workshops for process or product improvements at the San Diego, Tijuana, and other sites as required

• Communicates effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business unit projects and reports to meet established goals

Minimum Qualifications:

• Bachelor's degree Engineering or other technical field

• Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class II or III devices, or Pharmaceuticals

• Minimum 5 years of direct management experience

• Expert knowledge of 21 CFR Part 820, 21 CFR Part 803, 21 CFR Part 806, ISO 13485, ISO 14971, and other international standards, as required

• Expert knowledge of design controls and risk management

• Experience in front room and support room during internal and external audits

• Experience in navigating complex regulatory and product certification landscapes

• Knowledge and experience in making field action and non-field action decisions

• System-level thinking: ability to design, develop, and maintain complex systems, focusing on the overall architecture and functionality rather than individual components

• Critical thinking: problem identification, analysis, and formulation of conceptual / technical and business solutions

• Continuous improvement and influence: Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence

• Excellent written and oral communication skills; demonstrated through provided examples of appropriate written communication where possible

• Excellent strategic planning and prioritization skills

• Strong knowledge and demonstrated examples of influencing, coaching, and people development

Preferred Qualifications:

• Advanced degree in Engineering or other technical field

• Experience as head of QA for a site/business unit having broad responsibility for both product lifecycle and quality system processes

• Experience leading Quality function requiring technical product expertise (Design Assurance, Quality Operations, etc.)

• Experience in full Medical Device product lifecycle. I.e. Demonstrated medical device knowledge from initial conception to final decommissioning and disposal, including design controls, risk management, design transfer to manufacturing/servicing, and post market assessment

• Experience building a team from the ground up

• Certifications for lead auditor, Six Sigma, project management, technical writing

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.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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

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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.

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