Regional Quality System Manager Health Care
Category: Supply Chain
Work Location: Sant Joan Despi, Cataluña
Posted Date: February 11, 2019
Ecolab is looking for a Regional Quality System Manager Health Care for Europe, who will be responsible for ensuring Quality System in Health Care division are established and maintained in accordance with applicable government regulations and standards in Europe.
The position will also act as project manager for quality to ensure our Ecolab Health Care plants and procedures meet the new MDR requirements not covered in the ISO 13485
- Responsible for ensuring Quality System requirements are established and maintained in accordance with applicable government regulations and standards in Europe. (e.g. ISO 13485, FDA 21 CFR 820 QSR, MDD 93/42/EEC).
- Project Manager for the roll out of MDR in Quality. This role will ensure our Health Care plants and procedures meet the requirements of the new MDR.
- Defining strategy for certification ISO 13485 and ensuring documentation with Plants and legal entities is aligned.
- Manages the overall audit program and CAPA program including internal, supplier and external audit (e.g. FDA). Directly interfaces with auditors and/or regulatory authorities
- Coordinates the forum for conducting management review and collects data for review. Accountable for reporting on the performance of the overall Quality System
- Works as a cross-functional QA interface towards all European Health Care Ecolab Facilities, RD&E, Marketing, Regulatory, Manufacturing and Supply Chain team
- Degree in Chemistry, Pharmacy, Engineering, Food Science, or related field with strong Chemistry component.
- Deep knowledge of quality management systems, standards and government regulations applicable to medical devices (e.g. ISO 13485, FDA 21 CFR 820 QSR, MDD 93/42/EEC, EU MDR).
- Project management. Ideally Green Belt, Black Belt certification.
- 5 years working experience with quality management system, standards and government regulations applicable to medical devices (e.g. ISO 13485, FDA 21 CFR 820 QSR, MDD 93/42/EEC, EU MDR)
- Ideally several years of work experience in medical device design & development, manufacturing and/or medical device quality assurance, including generation of detailed specifications and requirements
- Expertise in ISO 9001, ISO 22000 & 14001 and managing quality improvement projects.
- Project management experience. Ideally Green Belt, Black Belt certification.
- Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment.
- English Professional, ideally also able to speak and read French and Spanish. Effective oral and written communication skill set. Requires proficient presentation and technical writing abilities.
- Ability to work on multiple projects simultaneously.
- High leadership level.
- Ability to travel.