Senior Quality Specialist

Becton Dickinson Medical Devices
  • Milpitas, California
    15 days ago

    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.

    We are the people who give possibilities purpose

    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.

    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.

    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.

    Required Skills

    Optional Skills

    .

    Primary Work Location

    USA CA - Milpitas 155

    Additional Locations

    USA CA - San Diego (BDB)

    Work Shift

    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 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

    Numbers & Facts

    LocationMilpitas, California

    Skills

    • Analysis Skillsunmatched
    • Biologyunmatched
    • Chemistryunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Detail Orientedunmatched
    • Diagnostics Solutions/Softwareunmatched
    • Diseaseunmatched
    • Establish Prioritiesunmatched
    • External Auditunmatched
    • FDA Requirementsunmatched
    • Food Safetyunmatched
    • Healthcareunmatched
    • ISO (International Organization for Standardization)unmatched
    • Infection Controlunmatched
    • Informaticsunmatched
    • Internal Auditunmatched
    • Laboratoryunmatched
    • Manufacturingunmatched
    • Marketingunmatched
    • Medical Equipmentunmatched
    • Medical Productsunmatched
    • Multitaskingunmatched
    • Physicsunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Process Qualityunmatched
    • Project/Program Managementunmatched
    • Regulationsunmatched
    • Team Playerunmatched
    • Technical Leadershipunmatched
    • Technical Writingunmatched
    • Technical/Engineering Designunmatched
    • Water Quality Testingunmatched
    • Writing Skillsunmatched

    Be found by employers

    5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.

    Level up your application

    Professional resume templates

    Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.

    Free resume templates

    Free resume builder

    Improve your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.

    Free resume builder