Quality Audit Program Manager, Quality & Regulatory Compliance - Remote at Becton Dickinson NA in Franklin Lakes, New Jersey

Job Description:

Job Description Summary

As the Audit Program Manager, you will manage Quality Audit Programs including development, scheduling, and implementing plans for comprehensive quality system audits taking into consideration quality metrics, results of previous quality audits and external inspections, industry trends and the external regulatory environment.



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.



Primary Responsibilities

• Coordinates and conducts routine and focused quality system audits as assigned to assess compliance with domestic and international regulations and standards, and corporate, segment, unit, and local procedures and policies.


• Establishes audit teams through the use of qualified BD quality auditors and contracted auditors.


• Conducts Quality Audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures.


• Follows up with the auditee as required to compile information relating to the audits.


• Evaluates the adequacy of the provided evidence against the approved Audit Action Plan (AAP).


• In conjunction with management, develops plans to address inadequate AAP documentation when required.


• Maintains the audit system software database to record the status of all audits and associated actions.


• Provides periodic reports to management based on the audit statuses and defined metrics.


• Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.


• Interacts with individuals at various levels of the organization across multiple sites/BUs and at Corporate during and when following up on audits.


• Interfaces with BU and Local leadership teams and compliance personnel to establish and implement schedules for corporate audits and gain acceptance/understanding of identified non conformances without damaging the relationship with the site.

About You:

• B.S. Engineering, Chemistry, Biology or equivalent discipline, advanced degree is preferred.


• One of these certifications or equivalent is required: (Certified Quality Auditor/ISO Lead Auditor Certified, Certified Quality Engineer, Certified Manager of Quality / Organizational Excellence.)


• Exemplar Global ISO 13485 Lead Auditor Certification or equivalent (Preferred.)


• Minimum 10 years of experience work experience in the Quality organization of a Medical Device and/or pharmaceutical company. Experience with warning letters and other regulatory actions preferred.


• Minimum of 5+ years' experience in with auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.


• Demonstrated knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation.


• Extensive knowledge of medical device regulations, industry or international standards and ability to interpret and apply including FDA QSR, ISO 13485, MDSAP, and EU MDR/IVDR standards.


• Advanced knowledge of other international medical device regulations preferred (e.g., China, Saudi, Korea, etc.)


• Comprehensive understanding of auditing principles and ability to perform as a lead auditor


• Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical.


• Understands team functions, leadership techniques and project management methodologies.


• Excellent communication skills (verbal, written, and presentation).


• Understands how to present information to varying levels within the organization; strong analytical skills and effective project management and organizational skills are essential.


• Ability to effectively manage time and resources.

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 NJ - Franklin Lakes



Additional 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

$126,600.00 - $208,900.00 USD Annual Apply Now