medtechrec

Senior Quality Engineer

medtechrec  •  Kreuzlingen, CH (Onsite)  •  4 months ago
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Job Description

Responsibilities: 

  • Technical project management for development projects (scope, timeline, budget, resources, risks, deliverables)
  • Experience in the development/optimization of ceramic implants and leading interdisciplinary teams (R&D, QA, RA, production, purchasing, suppliers, external partners) including meeting moderation, decision gates and stakeholder reporting.
  • Hands-on development of products/components: concept, design, prototyping, test planning and technical evaluation
  • Responsibility for end-to-end design control (e.g., ISO 13485)
  • Coordination of laboratory and testing activities (mechanics, fatigue strength, material/surface characterization, and, if necessary, biocompatibility in consultation)
  • Support with root cause analyses and CAPA-related activities in collaboration with QA
  • Experience with ISO 14971 (risk management), MDR/CE, and possibly FDA/21 CFR 820.
  • CAD experience and technical understanding of tolerance management and manufacturing processes
  • Experience in dental/implantology (compatibilities, interfaces, clinical requirements)

Requirements:

  • Completed studies in mechanical engineering, medical technology, materials engineering, plastics/ceramics technology or similar.
  • Several years of experience in product development (ideally MedTech/Dental)
  • Experience in project management (internal/external), including planning, control and stakeholder management
  • Very good understanding of design control and technical documentation in a regulated environment (ISO 13485 / comparable)
  • Experience with verification/validation, testing methods
  • Structured, independent and goal-oriented work style
  • Reliability, accuracy and a strong commitment to quality
  • Strong communication skills (German & English)
medtechrec

About medtechrec

medtechrec is a consultancy specializing in recruitment services exclusively tailored for the ever-evolving medical device industry.

Boasting 13+ years in healthcare and medical device recruitment, medtechrec has a wealth of experience in Contingent, Search and Contract solutions.

We work closely with our clients to understand their goals and challenges, and develop solutions that address their specific needs.

Our dedicated departments focus on:

Commercial

The average Medical Device company is made up of 40% commercial employees.

We source Sales Reps all the way to CCO's.

QA / RA

We spend as much time finding you quality candidates as they will ensuring that your devices meet regulatory standards and safety requirements.

R&D

Engineers, Project Managers, Scientists and Technical Writers.

With a special focus on finding top graduates.

Clinical Affairs

Clinical Trial Managers, Coordinators, Data Managers, CRAs, Medical Writers, Regulatory Affairs Specialists, and Directors and Managers.

Human Resources

HR Managers, Talent Acquisition Specialists and Customer Service staff, to keep your business ticking.

Finance & Strategy

We have a broad network of Finance Professionals with a background in Medical Devices. Understanding M&A and strategy specifically.

Industry
HR & Recruiting
Company Size
1-10 employees
Headquarters
London, GB
Year Founded
Unknown
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