Senior Quality Manager
BD
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Job summary
Waters is seeking a Senior Manager, Quality Engineering to lead Quality Systems and Regulatory Compliance for the Micro Reagents manufacturing operations in Sparks, MD. The role ensures FDA QMSR, ISO 13485:2016, and MDSAP compliance while driving continuous improvement and audit readiness.
The position partners with Manufacturing, Engineering, Regulatory Affairs, and Operations to set quality strategies, develop talent, manage budgets, and maintain a culture of quality and compliance to deliver
Qualifications
- Experience with FDA QMSR, ISO 13485:2016, and MDSAP requirements.
- Proven ability to lead quality teams and drive objectives through influence and collaboration.
- Authorized to work in the US; no sponsorship available.
Responsibilities
- Lead Quality Systems and Quality Engineering activities supporting the Micro Reagents manufacturing operations.
- Develop, implement, and maintain QMS procedures, policies, and standards.
- Ensure compliance with regulatory standards (QMSR, ISO 13485, MDSAP).
- Provide interpretation and guidance on quality policies across the organization.
- Maintain audit readiness and drive CAPA processes for continuous improvement.
- Lead site leadership collaboration to achieve quality objectives and budgets.
Skills
Education
Job description
As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.
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.
The Senior Manager, Quality Engineering provides strategic and operational leadership for Quality Systems and Quality Engineering activities supporting the Micro Reagents manufacturing operations in Sparks, MD. This role is responsible for ensuring compliance with FDA, ISO 13485, and MDSAP requirements while driving continuous improvement, audit readiness, and Quality Management System effectiveness across the organization.
As a key member of the leadership team, this position partners closely with Manufacturing, Engineering, Regulatory Affairs, and Operations leaders to establish quality strategies, support business objectives, develop talent, and maintain a culture of quality and compliance. The Senior Manager, Quality Engineering plays a critical role in advancing operational excellence and ensuring the delivery of safe, effective, and compliant products.
- Lead Quality Systems and Quality Engineering activities supporting the Micro Reagents manufacturing operations.
- Develop, implement, and maintain Quality Management System (QMS) procedures, policies, and standards in compliance with regulatory and corporate requirements.
- Ensure compliance with FDA Quality Management System Regulation (QMSR), ISO 13485:2016, MDSAP, and other applicable regulations and standards.
- Provide interpretation and guidance on company-wide quality policies and procedures.
- Maintain appropriate quality oversight of all Quality Management System processes to support a continuous state of compliance.
- Support and strengthen site audit readiness through proactive quality system management and monitoring.
- Lead and support internal, external, customer, corporate, and regulatory audits and inspections.
- Ensure effective execution and continuous improvement of Corrective and Preventive Action (CAPA) processes.
- Partner with cross-functional teams to address quality and compliance risks and implement sustainable solutions.
- Support new product development and product enhancement activities by providing quality engineering guidance and oversight.
- Partner with site leadership to establish and execute quality objectives aligned with business priorities and key performance drivers.
- Develop and manage departmental budgets, schedules, performance metrics, and resource plans.
- Establish operational goals and ensure successful execution of strategic initiatives and quality improvement programs.
- Analyze performance trends and identify opportunities to improve efficiency, compliance, and overall quality system effectiveness.
- Contribute to the development and execution of quality and business strategies.
- Lead, coach, and develop Quality Engineering managers and professionals.
- Build organizational capability by identifying, developing, and mentoring high-potential talent.
- Foster a culture of accountability, collaboration, continuous learning, and operational excellence.
- Support succession planning and strengthen leadership bench strength across the organization.
- Delegate responsibilities appropriately while empowering team members to achieve results and grow professionally.
- Collaborate effectively with senior leaders and stakeholders across quality, manufacturing, engineering, operations, and regulatory functions.
- Influence decision-making and drive alignment on quality initiatives across the business.
- Facilitate resolution of complex issues while maintaining strong working relationships and a customer-focused mindset.
- Participate on site and enterprise leadership teams and represent Quality in key business discussions.
- Bachelor's degree in Engineering, Science, Quality, or another related technical discipline.
- Minimum of 6-8 years of progressive leadership experience in Quality Engineering, Quality Systems, Regulatory Compliance, or a related function within a regulated industry.
- Experience managing Quality Management Systems within a manufacturing environment.
- Experience leading quality teams and driving organizational objectives through influence and collaboration.
- Experience managing departmental budgets, work plans, and performance goals.
- Strong knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485:2016, and Medical Device Single Audit Program (MDSAP) requirements.
- Strong understanding of Quality Management Systems, quality engineering principles, and regulatory compliance.
- Proven ability to lead multiple priorities and execute strategic and operational objectives.
- Strong verbal and written communication skills with the ability to communicate effectively at all levels of the organization.
- Ability to build relationships, influence stakeholders, and drive results in a matrixed environment.
- Strong problem-solving, decision-making, and conflict-resolution skills.
- Experience developing and mentoring talent, including identifying and advancing high-potential associates.
- Demonstrated ability to lead teams through change while maintaining focus on business objectives and compliance requirements.
- Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.
- Medical device manufacturing experience.
- Experience supporting FDA inspections, notified body audits, or other regulatory assessments.
- Experience leading site-wide quality initiatives and quality system improvements.
- Lean Manufacturing, Operational Excellence, or Continuous Improvement experience.
- ASQ certification and/or advanced degree.
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
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.
USA MD - Sparks - 7 Loveton Circle
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
$149,600.00 - $239,400.00 USD Annual
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