Quality Analysis (QA)

Portland Resourcing are currently working with a global medical company in Switzerland. We are currently looking for 6 experts with strong FDA regulation knowledge.

If you do not live in Switzerland Portland Resourcing will assist you through the Swiss taxation and work permit requirements.

Requirements:

1) typical consultant profile and related consultancy experience in medical device regulated
environment (FDA)

2) HIGH UNDERSTANDING AND KNOW-HOW OF FDA REGULATION, related capacity of understanding the difference between remediation minimal requirement and remediation expanded requirements.

3) ability to work in autonomy in a production environment, independent in retrieving information

4) ability to deliver in accordance to timeframe target of single NCR remediation

5) consultant "spirit": capacity of delivery facing "limited data available" cases

6) pragmatic spirit

7) hands-on experience on the topic

8) previous top management experience is NOT considered a plus, the profile must be capable of deliver
and it is not required to coordinate resources or other consultants

9) Knowledge & experience on SAP

10) Good knowledge of Office package

11) Language skills: English mandatory, German and/or Italian would be a plus