Job Description Summary

Staff Quality Systems Specialist I – Lead Auditor is responsible for providing Quality and/or technical leadership/supervision to product/projects/systems and direct report teams. Directly accountable for multiple projects within department or has accountability for programs across multiple plants.

Conceptualizes, prioritizes and schedules project deliverables. Determines feasibility of project features, deliverables and resource availability to recommend viable options. Leads continuous improvement activities for the DS Quality System.

The Staff Quality Systems Specialist I – Lead Auditor is directly responsible to the WW Quality Systems Director for the DS-wide development, improvement and implementation of Quality Systems programs. The Staff Quality Systems Specialist I – Lead Auditor is accountable for assuring that all DS sites comply with ISO and FDA (or primary regulations of their respective countries) through the implementation of effective internal quality system audit program and ensuing effective corrective actions/ preventive actions.

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. 

DUTIES, RESPONSIBILITIES & AUTHORITIES:

The Staff Quality Systems Specialist I – Lead Auditor is the QS Subject Matter Expert in one or more areas.

• Collects, interprets and analyzes data and presents to others either orally or in writing.  Understands and leverages published Quality System and regulatory agency requirements and leverages best practices.  Makes recommendations for project direction including alternative solutions. 

• Independently designs quality plans consistent with project objectives.  Readily applies Quality System principles to the solution of complex technical problems.

• Acts independently, consults with supervisor on unusual situations.

• May train, develop or assign work to others; provides technical and or supervisory guidance to others.  May be responsible for on contribute to the assessment and development of associates who are dotted line reports.  May have direct reports.

• Responsible to maintain budget as assigned and assure balance of resource allocation, dollars and equipment.

• Is the prime technical contact on projects and interacts with senior external personnel.

Specifically:

• Develops, documents, administers, and maintains Quality Systems for conformance to regulatory requirements and company policies.

• Develops, documents and executes Baltimore wide Quality Audit Program.

• Coordinates with other DS sites to assure that each site has fully compliant Quality System Audit Program.

• Develops and implements DS wide audit report “Peer Review” program so that audit reporting across the business is uniform, current and effective.

• Supports DS wide Quality System Audit Program by providing independent auditing service when there is a need for support in any particular site.

• Initiates a DS wide Audit Data Trending Programs for management input.

• Supports DS wide continual improvement effort by continually raising the compliance bar during Quality System Audits.

• Assures appropriate corrective action program is implemented for nonconformance issued during internal audits.

• Represents BDDS on cross-business teams related to Quality System Audits.

• Functions on corporate initiated teams regarding implementation and best practice strategies for highly visible Quality System Audit programs.

• Identifies best practices between BD divisions and Corporate to develop one common system.

• Develops and provides compliance/ audit training, including training for auditors and auditees.

• Partners with other quality professionals to address recurring issues identified throughout the organization.

• Provides and analyzes organizational quality audit metrics as required to generate quality system improvements.

MINIMUM QUALIFICATIONS:

KNOWLEDGE AND SKILLS: 

• Demonstrated ability to lead, motivate and accomplish results through experienced direct reports and peers.

• Ability to organize and prioritize assignments providing direction to assigned functional teams.

• Demonstrates effective written and verbal communication skills across all levels.

• Ability to speak with clarity and manage conflict resolution in a variety of settings; one-on-one interactions, group meetings, and formal presentations.

• Ability and skill to effectively manage multiple tasks and lead execution of change management plans.

• Ability and skill to lead or manage the Quality System function for complex systems, continuous improvement projects and project management techniques.

• Ability to act as a liaison across functions and with outside customer representatives or stakeholders concerning operational or project schedules/deliverables, audits, etc.

• Thorough knowledge and understanding of the food and Drug Administration (FDA) 21 CFR 820 and International organization for Standardization (ISO) and other worldwide regulations.

EDUCATION AND EXPERIENCE: 

• BS Degree in Life Science, Engineering or equivalent program.

• RABQSA or equivalent certification is highly preferred. Other Professional certification is an advantage (i.e, CQA, CQE, SQE, CQM, Etc)

• A minimum of 7-10 years experience in Quality Management/Quality Systems/ Audit Program Management.

• FDA and other MDR/IVDR Regulatory inspection experience.

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. #CLOLI

Required Skills

Optional Skills

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Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

US BD 1st Shift 830am-5pm (United States of America)

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

$113,400.00 - $186,900.00 USD Annual