Senior Quality Specialist

We Are The People Who Give Possibilities Purpose

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation, 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.

Job Description

Job Responsibilities:

• Develops and implements QMS integration plans.
• Coordinates the execution of QMS integration plans in collaboration with stakeholders and in accordance with business priorities.
• Drives execution of integration related activities, including but not limited to labeling changes, procedure updates, training updates, etc.
• Assists with NB, Corporate and other regulatory, external, and internal audit readiness.
• Assist with execution of internal audits.
• Applies quality and/or standard-setting body requirements to develop solutions, control and/or maintain technical documents and/or Quality Systems.
• Trains, develops, and provides technical guidance to other associates.
• Actively participate in quality guidance and helps project & quality network teams for process improvement, standardization initiatives, and continuous improvement activities.
• Completes projects/other duties as assigned.

Education and Experience:

• Requires a bachelor's degree in an Engineering or relevant Scientific discipline.
• A minimum of 5 years of relevant experience or a combination of equivalent education and relevant experience.

Knowledge and Skills:

• Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, IVDD, EU IVDR, Canadian MDR, Japan PMDA as well as ANVISA and TGA requirements.
• In-depth understanding of the application of quality systems to the medical device industry.
• Experience supporting internal and/or external audits.
• Proficient with electronic document and change management systems.
• Exceptional attention to detail & strong project management skills.
• Excellent technical writing skills and communication skills at all levels both written and verbal.
• Ability to set and deliver to specific goals and targets.
• Ability to perform multiple tasks and prioritize workload.
• Effective analytical, technical, and problem-solving skills.
• Effective meeting and presentation skills.
• Effectively manage conflict.
• Ability to work in or direct teams to obtain results.
• Self-motivated /directed.

Why Join Us?

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.

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.

Primary Work Location

USA CA - Milpitas 155

Additional Locations

USA CA - San Diego (BDB)

Work Shift

Our Commitment To You

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.

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 rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. 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.

Salary Range Information

$135,500.00 - $216,800.00 USD Annual