Design Assurance & Quality Engineer Medical Devices (m/f/d, freelance or temporary, 100%)

Congenius AG; Basel; Vor Ort; CHF 90’000 - 120’000; Vollzeit

Zusammenfassung

A leading company in the medical technology sector seeks a Design Assurance & Quality Engineer. The role involves leading quality engineering projects for medical devices, focusing on compliance, design control, and collaborating with interdisciplinary teams. Opportunity for growth in a dynamic environment with flexible hours and a supportive atmosphere.

Leistungen

Flexible working hours

Very good social benefits

Modern working conditions

Collegial cooperation

Qualifikationen

• 5+ years’ experience in design assurance and quality engineering of medical devices.
• Fluent in English; German is a plus.
• Strong analytical and systematic thinking.

Aufgaben

• Execute design assurance projects independently at customer sites.
• Lead international project teams ensuring quality compliance.
• Maintain technical documentation in compliance with regulations.

Kenntnisse

Design control processes

Design verification

Risk management

Problem-solving

Team collaboration

Communication skills

Ausbildung

Bachelor of Science (BSc) in Mechanical Engineering or Natural Science

Jobbeschreibung

Design Assurance & Quality Engineer Medical Devices (m/f/d, freelance or temporary, 100%)

Design Assurance & Quality Engineer Medical Devices (m/f/d, freelance or temporary, 100%)

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Direct message the job poster from Congenius AG

Congenius provides tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device, IVD and pharmaceutical industry. If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the MedTech industry, then joining our dynamic team could be your next rewarding career step.

Your Responsibilities

• Execute projects for customers independently (usually on customer's site) regarding design assurance and quality engineering for medical devices and combination products
• Lead work packages and ensure the quality of medical devices within international project teams, interacting with intercompany disciplines (development, production, regulatory, quality)
• Establish and maintain the technical documentation according to applicable regulations (e.g., MDR, 21 CFR Part 820)
• Solve problems and find solutions with the right balance between state-of-the-art technology, business needs, and compliance
• Act as an integrator between teams and sites
• Advise and consult customers and suppliers (take indirect leadership as appropriate)

Your Skills and Experience

• Education in mechanical engineering or natural science, at least Bachelor of Science (BSc)
• At least 5 years’ experience in design assurance, device development, or quality engineering of medical devices / combination products
• Very good knowledge of design control processes, design verification, and risk management
• Independent, self-organized, and hands-on approach
• Systematic and analytical thinking with strong problem‐solving capability
• Team player who works efficiently and flexible in interdisciplinary teams
• Decision-maker, taking the lead where appropriate and necessary
• Very good communication skills and ability to gain trust with various stakeholders (from shopfloor to senior management)
• Fluent in English is a must, German is a nice to have
• You will work in the Basel or Bern area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
• You benefit from flexible working hours and an exciting and versatile field of activity
• You work in a company with a flat hierarchy, short decision-making processes
• You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
• You benefit from modern and attractive working conditions and development opportunities
• An attractive salary and very good social benefits round off the offer

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Project Management, Consulting, and Engineering

• Industries

  Operations Consulting, Business Consulting and Services, and Pharmaceutical Manufacturing

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