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Lead Auditor - Quality Systems

Apply Now Job ID R-27005 Date posted 01/17/2018

Job Description Summary

The Lead Auditor - Quality Systems is responsible for providing Quality and/or technical leadership/supervision to product/projects/systems and direct report teams. This position is directly accountable for multiple projects within department or has accountability for programs across multiple plants.

This position conceptualizes, prioritizes and schedules project deliverables, determines feasibility of project features, deliverables and resource availability to recommend viable options, and leads continuous improvement activities for the DS Quality System.

This position is also directly responsible to the WW Quality Systems Manager for the BDDS-wide development, improvement and implementation of Quality Systems programs, and 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

RESPONSIBILITIES:

  • The Staff Quality Systems Specialist II – 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.
  • 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.

REQUIREMENTS:

  • BS Degree in Life Science, Engineering or equivalent program.
  • 10+ years experience in Quality Management/Quality Systems/ Audit Program Management.
  • RABQSA or equivalent certification. Other Professional certification is an advantage (i.e, CQA, CQE, SQE, CQM, Etc)
  • FDA and other MD/IVD Regulatory inspection experience.
  • Auditor Certification for ISO 13485: 2016, ISO 9001:2015 and MDSAP Participating countries

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.

# LI-OPS

Primary Work Location

USA MD - Baltimore

Additional Locations

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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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com