Quality Manager

Manager of Design Quality and Risk Functions within Infusion PlatformWe are the makers of possibleBD 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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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.Job Summary:The Quality Manager - Design Assurance will lead and manage all quality activities related to the design, development, and transfer of medical devices to manufacturing. This role ensures compliance with all applicable regulations, standards, and internal quality system requirements throughout the product lifecycle.Job Responsibilities:Lead and manage a team of Design Assurance engineers, providing guidance, mentorship, and performance management.Develop, implement, and maintain design control procedures, ensuring compliance with FDA QSR, ISO 13485, MDR, and other relevant regulatory requirements.Act as the primary Quality representative on new product development and sustaining engineering projects, ensuring quality is built into the design process.Oversee the generation and review of design input requirements, design outputs, design reviews, design verification and validation plans and reports.Manage risk management activities throughout the product lifecycle, including FMEA, hazard analysis, and risk management files.Ensure the effective transfer of design to manufacturing, including process validation, DHF completeness, and production control plans.Participate in internal and external audits, including FDA inspections, Notified Body audits, and customer audits.Drive continuous improvement initiatives within the Design Assurance function and across the Quality Management System.Collaborate cross-functionally with R&D, Regulatory Affairs, Manufacturing, and other departments to ensure product quality and regulatory compliance.Develop and deliver training on design control and quality system processes.Manage supplier quality activities related to design and development, including supplier qualification and monitoring.Job Qualifications:Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or a scientific discipline. Master's degree preferred.Minimum of 8 years of experience in Quality Assurance within the medical device industry, with at least 2-3 years in a leadership or management role focused on Design Assurance.Extensive knowledge and practical application of medical device regulations and standards, including FDA 21 CFR Part 820 (QSR), ISO 13485, ISO 14971, and EU Medical Device Regulation (MDR).Demonstrated experience with product development, design controls, and design verification/validation methodologies.Expertise in product risk management and hands on experience developing and maintaining a Product's Risk Management File.Proven ability to recruit, lead, motivate, and develop a team of quality professionals.Strong analytical, problem-solving, and decision-making skills.Excellent written and verbal communication skills, with the ability to effectively communicate complex technical and regulatory information.Experience with various quality tools and methodologies (e.g., FMEA, SPC, Root Cause Analysis).ASQ certifications (e.g., CQE, CMQ/OE, CRE) are highly desirable.At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.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.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.Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.