BD
Director of Product Quality and Communications (PQC)
BD, San Diego, California, United States, 92189
Director of Product Quality and Communications (PQC)
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and 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. Overview
We are seeking a leader to head the Product Quality and Communications (PQC) team, responsible for regulatory communications, quality commitments to regulators, and CAPA processes to align cross-functional areas with external regulatory expectations across the MMS BU. Responsibilities
Facilitate collection of information and technical writing of communications with FDA and other regulatory agencies, including periodic reports for audits and inspections, enhanced post-market surveillance reports, field remediation reports, Additional Information Requests related to adverse events, device malfunctions, recalls, and other communications. Facilitate implementation of commitments made to FDA and other regulatory agencies, including end-to-end process improvements, procedural updates, and design/manufacturing/labeling changes. Coordinate and facilitate a unified approach for CAPA initiation determination, leading to CAPA creation, product investigations, and escalation to Field Action decisions as applicable. Collaborate 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 communications. Actively participate in inspections and audits at sites as required, including pre-inspection activities, inspection management, responses, and remediation. Participate in workshops for process or product improvements at designated sites. Communicate effectively with all levels of management and business units, prioritizing projects and reports to meet established goals. Minimum Qualifications
Bachelor's degree in Engineering or another 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 navigating complex regulatory and product certification landscapes. Knowledge and experience in making field action and non-field action decisions. System-level thinking and ability to design, develop, and maintain complex systems. Critical thinking and ability to formulate conceptual/technical and business solutions. Continuous improvement mindset with ability to lead process excellence initiatives. Excellent written and oral communication skills; demonstrated through provided examples where possible. Strong strategic planning and prioritization skills; demonstrated influencing, coaching, and people development. Preferred Qualifications
Advanced degree in Engineering or another technical field. Experience as head of QA for a site/business unit with broad responsibility for product lifecycle and quality system processes. Experience leading Quality functions requiring technical product expertise (Design Assurance, Quality Operations, etc.). Experience in full Medical Device product lifecycle, 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, and technical writing. Why Join Us?
BD offers a culture that values your opinions and contributions, supports authentic collaboration, and emphasizes accountability, learning, and improvement. You will work with inspirational leaders and colleagues who are committed to fostering an inclusive, growth-centered, and rewarding culture. BD University provides opportunities to level up technical skills and expertise. To find purpose in the possibilities, we need people who see the bigger picture and understand the human story behind our work. Join us to reinvent the future of health and help make the world a better place. Location & Employment Details
Primary Work Location:
USA CA - San Diego TC Bldg C&D Employment type:
Full-time Salary Range Information:
$179,200.00 - $322,500.00 USD Annual
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BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and 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. Overview
We are seeking a leader to head the Product Quality and Communications (PQC) team, responsible for regulatory communications, quality commitments to regulators, and CAPA processes to align cross-functional areas with external regulatory expectations across the MMS BU. Responsibilities
Facilitate collection of information and technical writing of communications with FDA and other regulatory agencies, including periodic reports for audits and inspections, enhanced post-market surveillance reports, field remediation reports, Additional Information Requests related to adverse events, device malfunctions, recalls, and other communications. Facilitate implementation of commitments made to FDA and other regulatory agencies, including end-to-end process improvements, procedural updates, and design/manufacturing/labeling changes. Coordinate and facilitate a unified approach for CAPA initiation determination, leading to CAPA creation, product investigations, and escalation to Field Action decisions as applicable. Collaborate 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 communications. Actively participate in inspections and audits at sites as required, including pre-inspection activities, inspection management, responses, and remediation. Participate in workshops for process or product improvements at designated sites. Communicate effectively with all levels of management and business units, prioritizing projects and reports to meet established goals. Minimum Qualifications
Bachelor's degree in Engineering or another 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 navigating complex regulatory and product certification landscapes. Knowledge and experience in making field action and non-field action decisions. System-level thinking and ability to design, develop, and maintain complex systems. Critical thinking and ability to formulate conceptual/technical and business solutions. Continuous improvement mindset with ability to lead process excellence initiatives. Excellent written and oral communication skills; demonstrated through provided examples where possible. Strong strategic planning and prioritization skills; demonstrated influencing, coaching, and people development. Preferred Qualifications
Advanced degree in Engineering or another technical field. Experience as head of QA for a site/business unit with broad responsibility for product lifecycle and quality system processes. Experience leading Quality functions requiring technical product expertise (Design Assurance, Quality Operations, etc.). Experience in full Medical Device product lifecycle, 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, and technical writing. Why Join Us?
BD offers a culture that values your opinions and contributions, supports authentic collaboration, and emphasizes accountability, learning, and improvement. You will work with inspirational leaders and colleagues who are committed to fostering an inclusive, growth-centered, and rewarding culture. BD University provides opportunities to level up technical skills and expertise. To find purpose in the possibilities, we need people who see the bigger picture and understand the human story behind our work. Join us to reinvent the future of health and help make the world a better place. Location & Employment Details
Primary Work Location:
USA CA - San Diego TC Bldg C&D Employment type:
Full-time Salary Range Information:
$179,200.00 - $322,500.00 USD Annual
#J-18808-Ljbffr