Description
Medical Devices Company in Switzerland, Zurich area - is searching for- SENIOR VALIDATION SPECIALISTS -
the positions are open for a freelance consultant and a permanent candidate.
Please apply if you are available now or very soon.
The freelance candidate should be available 100% on site
The permanent candidate should be living in the Zurich area and available soon.
DESCRIPTION
QA Validation of all manufacturing processes and in-process tests for the manufacture of an active implant (Class III). Where appropriate work with manufacturing and engineering to introduce and validate new process to improve manufacturing predictability and robustness. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented through change control management. Final documents may be included in regulatory submissions and made available as needed during compliance audits.
RESPONSIBILITIES
* Generate, execute and review qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
* Analyze testing results using statistical techniques and determining acceptability.
* Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
* Generate documentation consisting of process specifications, FMEAs, test plans and reports.
* Validation of software controlled test equipment used during in-process inspection.
* Review, edit and approve change control, SOPs, deviations, CAPAs, and other applicable documentation.
* Lead cross-functional teams to plan and facilitate Qualification/Validation activities across the site.
REQUIRED SKILLS / EXPERIENCE
* Demonstrated ability to develop a "hands-on" approach, requiring personal initiative and responsibility while operating at a high level of performance and efficiency.
* Strong technical expertise when reviewing and approving SOPs, protocols, change controls, deviations, and validation maintenance.
* Experience with statistical techniques.
* Capacity for leading effective meetings, making independent decisions, meeting program and Validation management intent.
* Proven leadership qualities, including team building skills, to facilitate completion of tasks.
* Strong Interpersonal, oral, and written communication skills.
* Proficiency in German and English.
* BS/BA in Engineering or Life Sciences with a minimum of 4 years of related experience within the field of medical device Validation or QC.
* Master's Degree, or equivalent work experience, a plus.
Please respond stating relevant details as:
- Perm or Freelance interest
- earliest availability (Date/ notice period for permanent/ % for freelance)
- Salary expectations / hourly rate
- please add your current CV in Word Format
Please be so kind and provide me with this details as they will help me to manage the process more quickly and I will get back to you shortly.