Do you want to work in an international healthcare environment?
We are looking for a Quality Engineer for a temporary assignment of 1 year with the possibility to have a permanent contract after it.
Our client is located 30 minutes from Neuchâtel.
Your tasks:You will conduct investigations, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. You will escalate quality issues as appropriate.
You analyze effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
You conduct periodic line audits to assess for production controls. You review results of area audits to ensure that corrective and preventive actions are adequate.
You provide guidance to project teams and business partners to ensure compliance with company policies and procedures as well as medical device regulations.
You support the development of quality strategies related to the transfer of products, materials and components.
You support new product introduction as part of design transfer.
You ensure effective quality strategies for validation
You carry out Validation Assessment and FMEA
You ensure appropriate application of process validation,
Your profile:
You are an engineer ETS/EPF with minimum 5 years of experience as quality engineer in the medical device sector or pharma industry
Knowledge of product/process Risk Management (FDA and ISO standards) is required.
You have a good knowledge of ISO 9000, ISO 13485 and the GMP knowledge.
You have a good level in written and spoken English
Offer:
You will work in an international environment in the healthcare industry.Our client has a work culture around integrity, ingenuity and inspiration. You could be part of that community.