International Quality Assurance Officer M/F
As part of our recruitment activity, we are looking for an International Quality Assurance Officer M/F for our client specializing in the medical sector.
Your missions: Support international sales subsidiaries regarding the quality aspect Working in a pair within the Subsidiary QA department, the main missions will be as follows:
- Quality support for international UM sales subsidiaries:
- Drafting and monitoring the annual audit plan
- Monitoring actions following subsidiary audits
- Participating in subsidiary audits according to the audit schedule
- Preparing quality meetings with subsidiaries and monitoring actions
- Providing support to subsidiaries for all requests related to quality and product data
- Evaluation and monitoring of international distributors (from a quality perspective):
- Participating in distributor approval: evaluation of the quality questionnaire and documentation, drafting approval files
- Carrying out the annual evaluation of distributors, in connection with the subsidiaries
- Drafting and monitoring the annual audit plan
- Monitoring actions following distributor audits
- Providing support on quality systems:
- Proposing improvements to quality processes
- Participating in the preparation and execution of management reviews and quality committees
- Drafting and monitoring instructions/procedures/forms associated with the activity
- Participating in audits by health authorities/notified bodies or other authorities
- Participating in the management of change control and CAPA
Are you curious, rigorous, and do you enjoy working in an international environment? Do you want to put your quality expertise at the service of teams spread across several countries? This position is made for you!
- Training & experience
- Higher education in Quality, Health, Biology or a similar field (Bac+3 to Bac+5)
- First experience of at least 1 year in the medical device or pharmaceutical industry
- Technical skills: Imperative mastery of ISO 13485
Knowledge of the medical device / GXP environment would be a real asset Fluent English, both written and spoken: indispensable for daily exchange with international subsidiaries Good mastery of the Pack Office
Your qualities: Comfortable with written and oral communication Rigorous and endowed with good analytical skills Organized and capable of managing several subjects in parallel Possessing excellent interpersonal skills Comfortable working in a team and in an international environment Proactive and oriented towards continuous improvement