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Director, Quality Program – EU MDR/IVDR

Apply Now Job ID R-334938 Date posted 04/09/2019

Job Description Summary

Reporting to the Senior Director, Corporate Quality Systems, the Quality Program Director, assumes responsibility for the Program management activities for the global BDX quality organization for the effort to update quality systems for European Medical Device Regulation (EU MDR) and In Vitro Diagnostics Regulation (IVDR) changes.

This role is a 24 month assignment.

Job Description

This position is responsible to lead program management activities for the BDX quality for compliance of quality systems to meet to EU MDR /IVDR requirements.  These specific activities include; but, are not limited to:

  • Strategic Planning & Leadership:  Collaborates with the Corporate Senior Director, Quality Systems, aligning with the Senior Leadership of Quality and Regulatory within the Business Units and Regions, to develop and implement project planning for Quality System readiness.
  • Build & Develop Quality & cross functional team to support activities for Quality Systems  
  • Evaluates and reviews QS elements for EU MDR/IVDR compliance and progress.
  • Identifies and implements opportunities for continued improvement while meeting new requirements:
    • Baselines the current QS element, establishes relevant metrics with common definitions and identifies areas of improvement.
    • Collaborates with all business units, manufacturing sites, distribution centers, and/or regions on any requests/ suggestions for QS element improvement opportunity.
    • Works in partnership with other Network Leaders / BU Quality System Leaders for the support of the global quality system.
  • Organizational Consulting/Change Management:  Continually assess the components of the Quality System, associated processes and electronic solutions via two way feedback from the Businesses, Plants, Regions, and networks to provide continual improvement.
  • Identifies, communicates, resolves, and escalates any quality system related risk that may potentially derail/delay objectives or adversely affect the Quality System.
  • Ensures effective adoption, implementation and review of quality programs, collaborates with relevant management to gain buy-in/ownership of quality initiatives.
  • Analyzes, trends, and communicates all improvement opportunities to the appropriate senior management in an effort to enhance the Quality System.

Qualifications

  • Education:  BS in Science/Engineering or relevant discipline required.   Program Management Certification ,PMP, desired
  • Experience:  Eight or more years of Quality Assurance/Regulatory Compliance experience within an FDA regulated industry, preferably devices or diagnostics. Strong working knowledge of EU MDR /IVDR as well as 21 CFR820, ISO 13485, MDD, IVD, MDSAP and other global regulations.  Experience with medical devices and invitro diagnostics helpful.  Capable of assisting in the development of regulatory compliance strategies. 
  • Program Leadership:  Minimum of 8 years project/program management experience; must be credible as a ‘thought leader’ and able to inspire others, creating a dynamic environment that fosters innovation in thought and execution, as well as transparency; must be able to work collaboratively and lead influentially, must have exceptional judgment, integrity, and ethics.
  • Quality Systems Track Record:  Proven track record of significant accomplishments and innovation establishing progressive business practices with regard to quality systems.
  • Strategic Thinker/Change Agent:  Perceived as thought leader possessing knowledge of larger business picture.  Influential individual with the ability to work at all levels to educate and gain buy-in for all Network programs and initiatives; track record of creating a positive imprint on an evolving business; able to engage in strategic business discussion and communicate the value of quality programs and initiatives and the value of change.
  • Effective Trusted Communicator:  Demonstrate ability to effectively educate and influence other stakeholders of Quality Systems, encouraging ownership of quality vision and strategies; Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors.

  • Ability to travel up to 10%

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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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, or any other protected 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