BD (Becton, Dickinson and Company) Associate Director - Quality in San Diego, California

Job Description Summary

Job Description

Summary

The Sr. Manager/Associate Director, Infusion Specialty Disposables (ISD) Unit Quality Management reports to the ISD Director of Quality Management. The Sr. Manager/Associate Director, ISD Unit Quality Management is responsible for developing the MDS ISD Quality strategy in collaboration with the MDS WW VP, Senior Director, Quality Management and Director, Quality Management. The position also has the authority to assure that all BD MDS ISD products are designed and manufactured utilizing systems which comply with current Industry and Government Standards and conform to customer expectations for Safety and Effectiveness.

Responsibilities

  • Assume a leadership role in continuous improvement of current practice to improve quality and worldwide market share.

  • Develop the Unit Quality Management strategy in collaboration with the WW VP, Senior Director and Director, ISD Quality Management.

  • Execute, Measure and Report on the progress of the Quality Management Strategic initiatives.

  • Provide technical support to the Customer Facing Team to establish the ISD Product Value Stories.

  • Responsible for delivering key elements of the MDS and ISD Management Review (Product Performance Issues).

  • Assure Division wide policies, procedures and systems are designed and implemented to produce products which conform to established quality standards and comply with Industry and Government Standards.

  • Support manufacturing sites with appropriate technological and problem solving skills and resources to prevent and or minimize adverse situations.

  • Develop and continuously improve skills and adequacy of department resources in order to maintain appropriate levels of Quality Assurance.

  • Provide the required Quality Engineering support to the continuous improvement and business cost reduction efforts linked to operational effectiveness.

  • Maintain a constant level of current technology within the Quality Assurance function and share this technology with the entire organization.

  • Continuously apprise Senior Management of the level of quality throughout the Division.

  • Prepare, maintain, and adhere to approved departmental budget.

Qualifications

  • Bachelor's Degree required

  • A minimum of eight (8) years progressive experience in Quality Assurance within an FDA-regulated industry; QA administration and planning experience required.

  • Minimum 2 years of direct management experience

  • Strong understanding of medical device design assurance

  • Knowledge and experience in manufacturing, project management or engineering desirable.

  • Must possess excellent oral and written communication skills, and proven supervisory/leadership capability.

  • Management of QA professional and technical staff and non-exempt support personnel. Provide technical direction and coordination to all Plant Quality Assurance Managers.

  • Expertise in regulations affecting medical devices marketed in all regions throughout the world.

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

#LI-OPS

Primary Work LocationUSA CA - San Diego TC Bldg C&D

Additional Locations

Work ShiftNA (United States of America)

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