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Date: October 28th, 2016
Job profile: Quality Manager 70%-100% (m/f)
We are looking for a constructive and solution-oriented personality as Quality Manager. This position (70% or +) will be for an unlimited period of time, starting as soon as possible. Location: Basel, Switzerland
The jobholder will report directly to the CEO/CFO.
Responsibilities:
- Implementation, monitoring and maintaining of the Quality Management System according to EN ISO 13485 standard
- Quality planning (verification and validation)
- Assuring communication with internal and external stakeholders
- Addressing quality issues and implementing quality controls
- Execution of timely and objective internal and external audits (supplier audits and supplier evaluation)
- Responsible for risk management according to EN ISO 14971
- Initiation and monitoring of corrective and preventive actions
- Process validation, QA and QC monitoring and product release
Qualifications:
Education and experience
- University Degree in Molecular Biology or similar education, preferably with Ph.D.
- Further education in Quality Management
- At least 5 years of experience in Quality Management in IVD or Medical Device industry (Development and/or Production)
- Knowledge of EN ISO 13485 requirements
- Knowledge of current international standards, regulations and directives
- Hands on experience in quality assurance
- Regulatory, legal and QC assistance, working closely with other stakeholders on different levels
Soft Skills
- A team player with assertiveness and strong communication skills who shows flexibility especially within a start-up company
- Analytical thinking
- High accuracy in data management
- Goal oriented, self-motivated
- Well organized, plans with foresight
- Fluent in English and German, spoken and in writing
- Standard IT literacy
- Willingness to travel worldwide
We offer:
- Attractive working environment
- Supportive and understanding team for Quality
- Compensation commensurate for the position
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