Job Description Summary

QRC-JD-0009

This position is responsible for the implementation and oversight of the BD Quality Audit program.
In this role, she/he is responsible for implementing quality and regulatory audits of BD facilities and providing training and guidance for quality auditors. She/he is responsible for planning of required annual audits and other audits as needed.
She/he monitors the timely completion of corrective action plans and coordinates the reporting of compliance metrics to business unit/region and manufacturing facilities.
She/he uses training, experience, and the information collected during audits to assist BD facilities with problem solving and continuous improvement projects as assigned.
She/he functions as a subject matter expert for quality and compliance issues.

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. 

Job Summary:

This position is responsible for the implementation and oversight of the BD Quality Audit program.

In this role, they are responsible for implementing quality and regulatory audits of BD facilities and providing training and guidance for quality auditors. They are responsible for planning of required annual audits and other audits as needed.

They monitor the timely completion of corrective action plans and coordinates the reporting of compliance metrics to business unit/region and manufacturing facilities.

They use training, experience, and the information collected during audits to assist BD facilities with problem solving and continuous improvement projects as assigned.

They functions as a subject matter authority for quality and compliance issues.

Responsibilities:

• Coordinate and conduct 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, develop 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.

• Work in an office setting and be physically able to travel domestically and internationally (Travel is 25 - 50%).

  As part of a quality audit, must be able to enter Laboratory and Manufacturing environments that may have specific PPE and health requirements.

Qualifications:

• B.S. Engineering, Chemistry, Biology or equivalent field, advanced degree is preferred.
• One of the below certifications or equivalent: (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 abilityto 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 manage ment methodologies.

·Excellent communication skills (verbal, written, and presentation). Understands how to present information to varying levels within the organization.

·Strong analytical skills

·Effective project management and organizational skills are crucial.

Ability to effectively handle time and resources.

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