BD (Becton, Dickinson and Company) Quality Manager in Erembodegem, Belgium
Job Description Summary
Provide leadership in the implementation of the Quality Management System in compliance with the business unit requirements, ISO 13485/ 9001, US FDA 21 CFR 820 and other relevant GMP standards or (country specific) regulations. Responsible and accountable for the daily operation and maintenance of the Quality Management System (QMS), management of the outsourced process model (Legal Manufacturer) and finish goods and/ or component suppliers.
The job holder’s duties or responsibilities are not limited to those listed below. The job holder is expected to perform other duties and responsibilities as assigned by the Director Quality.
Establish and maintain the Quality Management System at all applicable locations to meet Legal Manufacturer requirements.
Maintain all applicable ISO, EC certificates and scope up (to liaise with NB and RA function).
Escalate compliance issues to BD Switzerland Sarl functional (QA and/or RA) and as appropriate top management.
Facilitate and participate in quality system document development and implementation.
Establish and maintain the internal quality audit schedule.
Establish quality management review presentations. Lead management review per business and quality agreement requirements.
Establish quality audit plans and reports as applicable.
Host notified body and corporate quality audits.
Establish and implement stakeholder service and/or quality agreements.
Establish and manage all quality elements to meet Orion requirements.
Establish and manage applicable quality elements for Erembodegem technical service site per Business requirements.
Plan and execute supplier quality audits, including creating audit reports, identifying proper corrective and preventive actions and closing out audit findings by working with suppliers.
Establish Quality Agreement and/or service agreements and perform contract review, determine supplier criticality and liaise with Procurement to establish new supplier or address on-going supplier issues.
Lead and/ or participate in customer audits as necessary.
Support regulatory for maintenance of registrations.
Deputize as management representative.
Key accountabilities are managing quality system, legal manufacturer requirements and supplier management.
Follow through on programs to achieve established objectives and targets and facilitate participation from other functional areas, as required, to achieve the objectives and targets.
Work independently with minimum supervision across multiple geographic.
Perform other duties as assigned.
Qualifications/ Leadership Expectations
Bachelor's degree required, graduate degree preferred
Identifies internal/ external business issues/ interdependencies to align operational priorities, strategies and tactics
Supplier management experience
Meet BD leadership standards
5-10 years experience required
ISO 13485, ASQ or IRCA Lead Assessor Certification or equivalent
Sound working knowledge of ISO 13485, 9001 and EU MDR/IVDR
Basic knowledge of US FDA QSR
Good understanding of root cause investigation, six sigma certification preferred
Good prioritization, organizational, interpersonal and analytical skills
Good written and oral communication in English
Excellent computer skills (MS Office, Project)
Primary Work Location
BEL Erembodegem - Dorp 86
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.