Job ID R-373838 Date posted 17/09/2020 BACK TO SEARCH RESULTS Apply

Quality Manager

Job Description Summary

The Quality Manager is responsible for the development, implementation and maintenance of the Quality Management System (QMS) which will support the Erembodegem Instrument Services Center (EISC) and the WEU Instrument Service team to drive Continuous Improvement. This QMS must meet the requirements of ISO 13485, US FDA 21 CFR 820, other applicable GMP standards and Regional as well as Country-Specific regulations. Additionally, you are supporting the management of the outsourced process model (Legal Manufacturer) of finished goods and/or component suppliers. The Quality Manager will support programs that achieve established Compliance requirements and Business objectives. In this key role, you will act as a single-level contributor and must work independently as a Subject Matter Expert.

Job Description

Quality Manager WEU Instrument Service Team

The Quality Manager is responsible for the development, implementation and maintenance of the Quality Management System (QMS) which will support the Erembodegem Instrument Services Center (EISC) and the WEU Instrument Service team to drive Continuous Improvement. This QMS must meet the requirements of ISO 13485, US FDA 21 CFR 820, other applicable GMP standards and Regional as well as Country-Specific regulations. Additionally, you are supporting the management of the outsourced process model (Legal Manufacturer) of finished goods and/or component suppliers. The Quality Manager will support programs that achieve established Compliance requirements and Business objectives. In this key role, you will act as a single-level contributor and must work independently as a Subject Matter Expert.

Your responsibilities will include:

  • Establishing and maintaining the Quality Management System in support of Business Unit objectives and Legal Manufacturer requirements.
  • Developing and implementing QMS processes and procedures.
  • Leading Quality Management Reviews.
  • Establishing and maintaining the Internal Quality Audit program.
  • Hosting Corporate Quality-, Notified Body- and Third-party audits.
  • Leading and participating in customer audits.
  • Executing supplier quality audits.
  • Creating and reviewing Quality Agreements and/or Service Agreements in support of business needs.
  • Performing Contract review, determining supplier criticality and working with Procurement to establish New Suppliers or address on-going Supplier issues.
  • Acting as Management Representative as required.
  • Maintaining all applicable ISO and EC certificates; interacting with Regulatory Affairs and Notified Bodies as required.

Your profile:

  • You have a bachelor’s degree (e.g. business administration and/or (mechanical) engineering).
  • You have 5-10 years of Quality Management working experience in strong quality regulated industry.
  • You have ISO 13485/ EU MDR/IVDR / US FDA QSR experience and are (preferably) ASQ or IRCA Lead Assessor Certified (or equivalent).
  • You have amazing prioritization, organizational, interpersonal and analytical skills.
  • You have experience with Establishing and Maintaining a Quality Management System.
  • You have Supplier Management experience.
  • You can identify internal/external business issues/ interdependencies to align operational strategies and tactics.

What can you expect from us?

  • A varied function with International contacts within a Company with an important social contribution in a value-driven organization.
  • An informal working atmosphere, dynamic Corporate culture and an environment that will challenge you as you grow and develop.
  • An attractive remuneration package.

Did we just describe your career aspirations? Click on the “APPLY” button and send us your application in English.Did we just describe your career aspirations? Click on the “APPLY” button and send us your application in English.

Primary Work Location

BEL Erembodegem - Dorp 86

Additional Locations

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