Senior Process Verification & Validation Engineer (80-100%)
This position is based in Bülach, Switzerland, responsible for the development, production, and marketing of balloon catheters and drug-coated stent systems.
The Verification & Validation department supports R&D, production, and regulatory affairs in the verification and validation of design, components, processes, and test methods.
This support includes knowledge transfer, active participation, and reviews.
Main Responsibilities
- Planning, conducting/coordinating, and documenting process V&V activities within development projects as part-project leader
- Reviewing associated documentation within development projects and supporting specialist departments in response to regulatory inquiries and audits
- Coordinating, leading, and evaluating first samples of external components as well as test method and process validations
- Planning, coordinating, and monitoring mechanical and analytical test procedures during validations as well as raw data evaluation, report writing, review, and approval
- Creating, reviewing, and approving documentation (specification and evidence documents) in compliance with quality requirements and regulatory standards until production handover
- Trend analysis, reporting, and presentations of quality-related data during the development phase
- Continuous improvement of processes and procedures (through evaluation and analysis as part of the trending) before project handover to production
- Supporting process development, test method development, and first sampling of external components during the development phase
- Accompanying equipment qualification during the development phase
Requirements for Education/Experience
- Completed degree in medical technology or equivalent training with at least 5 years of professional experience
- Product knowledge in the field of medical technology, vascular intervention, and combination products is advantageous
- Experience in process verification & validation
- Knowledge of international regulatory requirements in the field of process verification & validation and test method validations (including MDR, ISO 13485, 21 CFR 820, ISO 22515-7, MSA4, cGxP)
- Secure application of verification/validation testing methodology/tools as well as statistical methods
- Experience in defining, organizing, and leading subject-related work packages
- Very good German and English language skills in writing and speaking
Teleflex is an equal opportunity employer. Applicants are considered regardless of age, race, religion, skin color, national origin, ancestry, marital status, emotional or sexual orientation, gender identity or expression, disability, nationality, gender, or veteran status.
If you need support to apply for a position, please contact us: talent.emea@teleflex.com.
Diversity fosters innovative thinking and entrepreneurship, and that’s what makes us at Teleflex. We trust and value our employees and their diversity, and we make sure it’s fun to work here. We’ve set out to make sure our workplaces reflect the patients we serve and the communities where we operate. Our approach is simple: we include everyone and want them to feel they belong. We’re building a culture where all employees can bring their best and unique selves to work. If you’re inspired by this, we’d love to hear from you. Come join a company where diversity is welcomed and inclusion is the way we move forward.
Teleflex follows a comprehensive hiring process. We do not accept unsolicited applications from recruitment agencies or third parties. We do not make unsolicited job offers. We do not ask for money or require the purchase of equipment in advance.
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