We are recruiting for an experienced Medical Device Quality Professional with at least 5 years of relevant experience.
* Provide project direction and coaching for quality engineering and technical team personnel.
* Lead complex quality projects.
* Working knowledge of statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.).
* Working knowledge of risk assessment tools (e.g., ISO 14971, FMEA’s, FTA).
* Demonstrate working knowledge of Post Market Surveillance.
* Working knowledge of process validation strategies (inclusive of I/O/P).
* In-depth knowledge of Design Controls, CAPA, NC, etc.
* Support and lead product Design Control activities for new product development.
* Conduct and lead Process/Design Validation/Verification activities and approach including software validation.
* Conduct Process/Design Risk Analysis.
* Conduct Internal Audits of the Quality System.
* Conduct audits of new suppliers
PROFESSIONAL EXPERIENCE REQUIREMENTS:
* Strong quality engineering skills with a proven track record in design and process validation/verification and risk analysis is also required.
* Demonstrate strong project management skills.
* 5-10 years of direct and/or related quality work experience in a regulated environment.
* Knowledge of the CFR820 and ISO 134585 quality requirements.
* Excellent problem solving and decision making skills.
* Interpersonal skills that foster conflict resolution as it relates to technical situations.
* A minimum BS degree in a technical discipline with 5 years of related experience for Quality Engineer.
Please note, I can only accept applications from candidates who do not require a sponsor for a Swiss work permit.
Please send CVs or call +41 (0) 44 215 2051
Michael Bailey International is acting as an Employment Business in relation to this vacancy.