In this role, you will have the opportunity to:

• Manage site QMS implementation to minimize compliance risks. Ensure external audits by customers and regulatory bodies go according to plan. All findings and observations are closed on time and site responses accepted by the auditing bodies.

• Own customer audits to enable our site to serve more customers. Plan and schedule customer audits to maximize order intake.

• Organize site internal audits and host corporate level audits. Track all audit findings till closure.

• Create, manage, and approve audit records in company system for both external and internal audits.

• Drive site quality management improvement using DBS tools.

• Develop a quality culture among the site functions via training, quality kaizens and other quality events & activities.

• Report out on audit, QMS and training related KPIs.

The essential requirements of the job include:

• 3+ quality management system experience with a Master degree or 5+ quality management system experience with a Bachelor degree in a scientific field, preferable in Lifesciences (biomedical, chemistry, pharma,…)

• Skills:

o Language: English (written & spoken)

o Strong working knowledge of quality management system

o Familiarity with ISO9001

o Experience in a regulated industry preferred

o Good working knowledge of MS Office software

It would be a plus if you also possess previous experience in:

• Knowledge of ISO 13485 a plus

• Track record of successful external audit hosting.

• Strong interpersonal and communications skills

• Excellent planning, organization, and presentation skills

• Fast learner with good cross functional leadership capabilities

• Ability to multi-task, solve problems and make decisions

• Works collaboratively with other functions

其他信息
语言要求：英语
行业要求：全部行业