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Quality Assurance Specialist

vor 2 Monaten


Baar, Zug, Schweiz Medela Vollzeit
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Medela. As a Quality Assurance Specialist, you will play a critical role in ensuring the delivery of high-quality products to our customers.

Key Responsibilities
  • Support the quality function with document control, reviewing, and archival of documents
  • Update quality records in their respective storage locations, including technical files, supplier files, electronic quality handbook, and archiving
  • Support change management activities through initiation of change controls and maintenance of the change register
  • Plan and execute verification activities for manufacturing processes in support of product implementation
  • Initiate investigations, investigate, and implement Corrective Action and Preventive Action (CAPA) and verify effectiveness
  • Supplier management, plan, execute supplier audits according to audit program, and follow up on supplier corrective action requests
  • Contribute to new product introduction with quality-related activities during transfer of design, manufacturing line setup
Requirements
  • Bachelor's degree or equivalent in a relevant technical discipline
  • At least 3 years of experience working in quality assurance, ideally in a manufacturing environment
  • Knowledge of ISO 9001 Quality Management System (QMS), experience working with QMS for medical and non-medical products
  • Knowledge of CAPA, continuous improvement, problem-solving, 5S, Risk Assessment; experience in conducting internal audits and supplier audits (both onsite and remote)
  • English and German fluent written and spoken, combined with excellent communication skills
  • Knowledge of regulatory aspects related to cosmetic and medical device products is desired
  • Immediately available with motivation to cover the maternity leave of a team member for around 9 months
What We Offer
  • Medela Family: A culture characterized by inclusivity and respect that values and supports every member of our team
  • Flexibility: If your role allows for it, you can work in a hybrid model with up to 3 days per week working from home
  • Growth Opportunities: A range of learning initiatives, both on and off the job
  • Competitive package: Benefits align with international benchmarks, including extended maternity/paternity leave, insurance, and additional vacation or bridge days
  • Balance: A variety of activities designed to promote health and well-being