Sr.Staff Quality Specialist
Offer summary
Qualifications:
Bachelor's degree in a relevant field such as Quality Management or Life Sciences., Minimum 11 years of experience in quality management focusing on CAPA and audits., Strong knowledge of quality management principles and relevant regulations like FDA and ISO., Excellent analytical, problem-solving, and communication skills..Key responsabilities:
- Oversee the transition of audit findings to the CAPA system and ensure timely communication with stakeholders.
- Manage internal audit observations and collaborate with teams to ensure compliance with regulations.
- Prepare compliance reports for senior management and lead efforts to adapt to regulatory changes.
- Participate in continuous improvement initiatives related to the audit program.
Job description
Job Description Summary
We are seeking a highly motivated, collaborative, results-oriented and experienced Sr.Staff Quality Specialist to join our team and help us deliver innovative medical devices to patients around the world. As a Sr.Staff Quality Specialist, you will play a crucial role in managing, reporting, and monitoring internal audit nonconformances. This position involves overseeing audit records, executing relevant metrics and reports, and ensuring compliance with regulatory and quality standards. You will work closely with cross-functional teams to track audit commitments, develop audit responses and plans, identify and mitigate risks, and resolve challenges. The ideal candidate will have a proven track record in managing complex projects, with a strong understanding of project management principles, audits, regulations, and complianceJob 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.
This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through March 31, 2026.
CAPA Management:
1) Oversee the transition of audit findings from OneAudit system to the Corrective and Preventive Action (CAPA) in TrackWise.
2) Collaborate with cross-functional stakeholders to ensure proper, timely, and accurate transitions.
3) Maintain frequent communication on pertinent details of transitions with appropriate contacts.
Audit Coordination:
1) Manage internal audit observations.
2) Collaborate with cross-functional teams to ensure adherence to regulatory requirements and internal policies.
3) Identify appropriate owners for audit findings and monitor audit phase timeliness.
4) Serve as a liaison between owners and internal auditors.
5) Identify areas of non-compliance and work with relevant departments to develop corrective action plans.
6) Perform administrative tasks within the audit system, where appropriate.
Regulatory Compliance:
1) Stay up to date with relevant industry regulations and standards.
2) Ensure audit responses are complying and lead efforts to adapt to regulatory changes.
3) Prepare compliance reports for senior management.
Continuous Improvement:
1) Lead and participate in continuous improvement initiatives related to monitoring the audit program and overseeing audit phase execution.
Qualifications:
Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Life Sciences).
Minimum 11 years of experience in quality management with a focus on CAPA, audits, and regulatory compliance.
Strong knowledge of quality management principles, methodologies, and relevant regulations (e.g., FDA, ISO, GMP).
Proficiency in CAPA software and auditing tools (e.g., TrackWise).
Excellent analytical, problem-solving, and communication skills.
Certification in Quality Management (e.g., Certified Quality Auditor, Certified Lean Six Sigma) is a significant advantage.
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.
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.
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 https://bd.com/careers
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.
Required Skills
Optional Skills
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Primary Work Location
USA CA - San Diego TC Bldg C&DAdditional Locations
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 Our Commitment to You.
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
$155,900.00 - $257,300.00 USD AnnualRequired profile
Experience
Other Skills
- Quality Assurance
- Collaboration
- Communication
- Time Management
- Analytical Thinking
- Detail Oriented
- Problem Solving
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