Freelance QMS Manager

Key areas of responsibilities

• Ensures compliant and effective QMS´s are maintained in scope.

• Accountable for the transformation of all current QMS?s parts in scope towards the single PQMS structure.

• Accountable to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope.

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

• Ensures Q&R requirements are effective in all processes 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 degree in technical area with at least 3- 5 years of QMS management, experience in medical industries is a plus

• 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 advantage.

• Ability to interact professionally with all organizational levels

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

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

• Highly detailed oriented with strong organization and prioritization skills