QMS Manager

QMS Manager

Location: Best, Eidhoven

Contract: Permanent at a Randstad company

Hours/week: 40

Budget range: €5.500 - 6.250 per month

As the QMS manager in this position, you will ensure that the QMS system complies with all applicable regulations. Fix the QMS-related non-conformities. Improvise the CAPA procedures. Assist Team in ensuring a smooth switch from the present QMS to the new PQMS.

In this role You will be responsible for:

• Accountable to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope.Ensures compliant and effective QMS’s are maintained in scope.

• Be a part of the Transformation of all current QMS’s parts in scope towards the single PQMS structure.

• Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope.

• Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.

We are looking for:

• Bachelor’s degree in a technical area with at least 8 to 10 years of QMS management, and experience in medical industries. Strong experience with ISO 9001, ISO 13485

• Understanding and application of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR 820, EU Medical Device Directive (93/42/EEC), European Medical Device Regulation MDR 2017/745, ISO 13485, and MDSAP (including all member countries regulations) is an advantage.

• Excellent in stakeholder management.

• Must be results-driven - Able to manage competing priorities in a fast-paced environment

• Ability to communicate ideas and information clearly, effectively and concisely.