BD (Becton, Dickinson and Company) Associate Director Quality in Eysins, Switzerland

Job Description Summary

• Acts as the BD Switzerland Management Representative and ensures that the BD Switzerland QMS requirements are effectively established and maintained.

• Responsible for reporting on the performance of the BD Switzerland QMS to Top Management.

• Organises and runs the WWISD/MMS BDS management reviews, Toll manufacturing reviews and prepares the data for overall MDS management review contributions from WWISD.

• Acts on behalf of Top Management during Quality Audits.

• Is the conduit and expert for the implementation of MDR, maintenance of MDSAP and ISO13485:2016 for WWISD and BDS. Works effectively with notified bodies and represents the LM.

• Works with plant and unit quality leaders to ensure effective management and implementation of Swiss Model and processes. Acts as an integral part of QMS integration plans.

• Works with MMS Associate Director Quality to ensure appropriate QMS linkages are maintained/developed

• Works with the MMS and WWISD disposables platforms to provide guidance on QMS activities as necessary

• Contributes to functional strategy development

• Has in-depth functional expertise and broad business knowledge

Job Description

I. Main Responsibilities

  • Acts as the BD Switzerland Management Representative and ensures that the BD Switzerland QMS requirements are effectively established and maintained.

  • Responsible for reporting on the performance of the BD Switzerland QMS to Top Management.

  • Organises and runs the WWISD/MMS BDS management reviews, Toll manufacturing reviews and prepares the data for overall MDS management review contributions from WWISD.

  • Acts on behalf of Top Management during Quality Audits.

  • Is the conduit and expert for the implementation of MDR, maintenance of MDSAP and ISO13485:2016 for WWISD and BDS. Works effectively with notified bodies and represents the LM.

  • Works with plant and unit quality leaders to ensure effective management and implementation of Swiss Model and processes. Acts as an integral part of QMS integration plans.

  • Works with MMS Associate Director Quality to ensure appropriate QMS linkages are maintained/developed

  • Works with the MMS and WWISD disposables platforms to provide guidance on QMS activities as necessary

  • Contributes to functional strategy development

  • Has in-depth functional expertise and broad business knowledge

II. Duties/Accountabilities

  • Leverages methods and approaches for data collection from other internal/external sources and best practices to address complex processes, situations or issues

  • Applies multiple, complex functional principles and processes to address critical challenges

  • Utilizes deep expertise and contextual awareness to advise internal/external customers and stakeholders on complex issues in consideration of cultural implications and norms.

  • Leverages trend data and knowledge of past experiences to identify opportunities to improve existing practices and generate practical solutions

  • Leads team(s) through change efforts; collaborates with appropriate parties to translate strategies and plans into an effective change model that considers cultural and diversity implications

  • Identifies internal / external business interdependencies to align priorities, strategies and tactics

  • Effectively adapts to fluid situations and leads teams through ambiguity by establishing authentic communication efforts and two-way dialogue

  • Identifies optimal solutions to meet objectives, teaching others to approach solutions in a proactive and pragmatic way; stretches to exceed results in a timely and cost-effective manner

  • Makes decisions, often difficult and / or unpopular, that support the function's strategy; takes personal accountability for decisions made and gains the support of others

  • Acts as the management representative for BD Switzerland (MPS WWID and MMS) and products for which it is the legal manufacturer.

III Additional Qualifications

  • Bachelor's degree required, graduate degree preferred

  • 10 year’s experience required in Medical Device environment

  • 5 years management experience strongly recommended

  • Ability to lead and influence combined with good communications skill

IV Experiences

  • Clearly demonstrable experience in the following:

  • Quality Assurance/Control, Statistical analysis, FDA QSR’s (21 CFR Part 820), risk management (ISO 14971), MDSAP, ISO13485:2016, MDD to MDR transition

V. Required Knowledge and Skills

  • Knowledge and application of ISO 9001, ISO 13485, 21 CFR 820 and 21 CFR 210-211, MDR requirements and European/US GMPs related to medical device and pharmaceutical manufacture.

  • Experienced in project management.

  • Organisational / motivational skills.

  • Capable of managing a range of projects and activities in parallel.

  • The ability to manage by influence in addition to functional responsibility.

  • The preparation, planning and presentation of key initiatives.

  • The ability to coordinate effectively across regions.

Primary Work Location

CHE Eysins - Business Park Terre-Bonne

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.