Head of Quality Management (m/f/x) Malaysia
Produktion & Technik
Aufgaben & Ziele
Our client is an internationallly renowned supplier in medical goods. For a site in Malaysia with a total of six plants, we are looking for a Head of Quality (m/f/x) ad interim, who will also be responsible for the Global Quality Management of the Center of Excellence IV Access product line. Project start is January 2020 (or earlier) and will last until a permanent solution has been found.
- Support the Asia-Pacific Region on quality and Good Manufacturing Practice aligned with international regulations.
- Ensure the Quality Management System for Medical Devices and Pharmaceutical Products comply with international regulations such as US FDA 21 CFR 820, EU-MDD and MDR, PIC/S as well as with internal Global Quality Standards.
- Develop local quality objectives in line with the divisional strategy and quality targets.
- Promote customer requirements, product and process quality as well as compliance awareness throughout the organization.
- Lead and manage the Quality Organization (including both QA and QC) of the the malaysian company
- Lead the Regulatory Affairs function ofthe malaysian company.
The owner of the position will be responsible for a total of approx. 170 FTE and a total of six plants, all located in the same industrial area.
Anforderungen & Kenntnisse
- University degree, preferably in the field of engineering, pharmacy, chemistry, microbiology or similar.
- Minimum of 7 years relevant working experience in QM/QA in larger manufacturing units, preferably plastic technology.
- At least 5 years of experience as Head of Quality Management.
- System and methods knowledge per EU GMP/MDD/new MDR and FDA requirements.
- Leadership experience gained in a multi-national company. Know how to optimize interfaces within a matrix organization.
- International exposure in Asia Pacific region.
- Good stakeholder management skill.
- Ability to work independently and willingness to travel.
- Business-fluent English (Bahasa Malaysia, Chinese and German language is a plus).