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Senior CAPA & QMS Specialist
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Job Description
We are the makers of possible
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.
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.
Key Responsibilities:
1. CAPA Management: Lead and oversee the Corrective and Preventive Action (CAPA) process, from identification and investigation to implementation and effectiveness monitoring. Ensure timely and effective resolution of quality issues.
2. Audit Support: Support internal / external audits and track observations. Collaborate with cross-functional teams to ensure adherence to regulatory requirements and internal policies. Identify areas of non-compliance and work with relevant departments to develop corrective action plans.
3. Quality Compliance Programs: Monitor and ensure compliance to QMS. Facilitate process improvements. Monitor and report on compliance metrics and performance indicators.
4. Regulatory Compliance: Stay up-to-date with relevant industry regulations and standards. Ensure that the QMS remains in compliance and lead efforts to adapt to regulatory changes. Prepare and present compliance reports to senior management.
5. Continuous Improvement: Participate in continuous improvement initiatives related to QMS processes, procedures, and quality standards. Collaborate with cross-functional teams to ensure continuous improvement in compliance and quality processes.
Qualifications:
Attributes:
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.
Why Join Us?
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.
To learn more about BD visit
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
USA CA - San Diego Bldg A&B
Work Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under .
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$99,000.00 - $163,300.00 USD Annual
Job Description
We are the makers of possible
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.
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.
Key Responsibilities:
1. CAPA Management: Lead and oversee the Corrective and Preventive Action (CAPA) process, from identification and investigation to implementation and effectiveness monitoring. Ensure timely and effective resolution of quality issues.
2. Audit Support: Support internal / external audits and track observations. Collaborate with cross-functional teams to ensure adherence to regulatory requirements and internal policies. Identify areas of non-compliance and work with relevant departments to develop corrective action plans.
3. Quality Compliance Programs: Monitor and ensure compliance to QMS. Facilitate process improvements. Monitor and report on compliance metrics and performance indicators.
4. Regulatory Compliance: Stay up-to-date with relevant industry regulations and standards. Ensure that the QMS remains in compliance and lead efforts to adapt to regulatory changes. Prepare and present compliance reports to senior management.
5. Continuous Improvement: Participate in continuous improvement initiatives related to QMS processes, procedures, and quality standards. Collaborate with cross-functional teams to ensure continuous improvement in compliance and quality processes.
Qualifications:
- Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Life Sciences), preferred
- Minimum 5 years of experience in quality management with a focus on CAPA, audits, and/or QMS compliance.
- Proficiency in CAPA software and problem solving methodologies and tools. (e.g. Trackwise)
- Excellent analytical and communication skills.
- Strong knowledge of quality management principles and methodologies.
- Demonstrated experience in leading and participating in internal and external audits.
Attributes:
- Exceptional attention to detail and a commitment to data accuracy.
- Strong organizational and time management skills.
- Ability to lead and collaborate effectively in a cross-functional team environment.
- Analytical mindset with a passion for deriving insights from data.
- Demonstrated integrity in handling sensitive data and adherence to ethical standards.
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.
Why Join Us?
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.
To learn more about BD visit
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
Primary Work Location
USA CA - San Diego TC Bldg C&D
Additional Locations
USA CA - San Diego Bldg A&B
Work Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under .
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$99,000.00 - $163,300.00 USD Annual
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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