Quality Assurance Manager Design Controls

vor 1 Woche

Zug, Zug, Schweiz Belimed AG Vollzeit
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confidence Quality Assurance Manager Design Controls (m/f/d) Belimed AG is a leading supplier of medical and surgical instrument sterilization, disinfection, cleaning products and services. The company, with its headquarters in Zug (Switzerland), has offices in 9 countries around the world and is represented in over 80 countries thanks to a strong network of distributors. We look back on more than 50 years of history, continually evolving our technology-driven portfolio of high quality products and services. As Engineers of confidence, we build trust and value for our customers, empowering them to advance medical care and protect the lives of patients and medical personnel.

We believe that winning teams are the key to our success. In Belimed you will work in an international, open-minded and hands-on team in a growing industry, committed to improving the health of our society. Apply for this challenging role and join our HQ team in Zug.
How you will contribute The Quality Assurance Manager Design Controls ensures that quality standards and procedures in the field of Design Controls are met and aligned with legislation and customer specifications.

Your main tasks will include:
  • Responsible for application and management of the quality assurance policies in product development and product sustaining
  • Acts as independent reviewer within development projects, major changes
  • With his or her technical expertise, this person supports the organization in the assessment of possible hazardous situations
  • Manages and controls Post Market Surveillance system for all Belimed products
  • Act as project manager to coordinate solution of reported nonconformities managing investigations and CAPA measures
  • Provides quality and/or process improvement initiatives in the field of design controls in collaboration with other stakeholders such as Service, Operations, Product Management in order to enhance quality level of products and services on key issues
  • Supports assessment of compliance to horizontal and vertical directives, standards and regulations like 2017/745/EU, EN ISO 13485, 21CFR820, EN ISO 14971, EN ISO 62366, IEC , EN ISO 62304, EN ISO , EN ISO 62366, , EN IEC and others
  • Identifies and prepares relevant training needs and opportunities and conducts trainings in his/her field of expertise
  • Performs internal, external and supplier audits (preparation and execution), takes responsibility for corrective actions
What you will need
  • Engineering Degree (Bsc or Msc) in electrical or mechanical engineering
  • Further education in quality management or quality management or quality techniques desired
  • At least 3 years of experience within product development, development processes, preferably in an international environment
  • Experience in design controls, risk management and essential requirements for active medical products as an asset
  • Experience as project manager preferably in the medical device or other highly regulated industry
  • Knowledge on medical device quality requirements according to EN ISO 13485, 21CFR820, essential requirements according to MDR 2017/745 and MDD 93/42/EEC and on risk management procedures according to EN ISO 14971
  • detail-oriented while remaining a pragmatic approach/mindset
  • Strong interpersonal communication skills, ability to involve and motivate people to close issues successfully and in time
  • Ability to interact with auditors and field investigators
  • Ability to work independently and to manage multiple priorities, projects and tasks with minimal supervision
  • Presentation and training competences
  • German mother tongue, English B2 or higher
Why join our team Use your professional expertise and help us to protect the lives of patients and medical personnel. Join our ambitious team and share our strong customer orientation and sense of urgency. We offer you varied work in a hands-on, international environment with a strong, value-based company culture and a fair, performance-related compensation. Our culture of empowerment and accountability will give you easy access to key decision-makers and enable you to make a real impact.

If you recognize yourself in this career proposition, we look forward to receiving your application documents (CV, certificates, letter of motivation). To ensure the transparency of the selection process, we will only be able to consider electronic applications (via our online system); applications via e-mail or post will not be considered.

Join our winning team and take your career further.

>>> APPLY ONLINE NOW In case of dossiers from employment agencies, the terms and conditions for the placement are negotiated individually in each case. General conditions are not accepted.

Belimed AG processes personal data in accordance with the Belimed privacy statement available under:

Belimed AG
Laura Cunrady
Grienbachstrasse 11
6300 Zug

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