Quality Assurance Specialist

vor 4 Wochen

Baar, Zug, Schweiz Medela Vollzeit

As a Quality Assurance Specialist at Medela, you will play a crucial role in supporting our "Essentials" product portfolio related to all quality aspects and our quality management system. Your goal will be to continuously drive the implementation and improvement of processes and to verify manufacturing processes. You will work with internal stakeholders, customers, and suppliers on a daily basis to ensure the delivery of high product quality.

Key responsibilities include:

  • Supporting the quality function with document control, reviewing, and archival of documents
  • Updating quality records in their respective storage locations, including technical files, supplier files, electronic quality handbook, and archiving
  • Supporting change management activities through the initiation of change controls and maintenance of the change register
  • Planning and executing verification activities for manufacturing processes in support of product implementation
  • Initiating investigations, investigating, and implementing CAPA and verifying effectiveness
  • Supplier management, planning, executing supplier audits according to the audit program, and following up on supplier corrective action requests
  • Contributing to new product introduction with quality-related activities during transfer of design, manufacturing line setup

Requirements include:

  • 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 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 the 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

Medela offers a culture characterized by inclusivity and respect that values and supports every member of our team. We pursue one goal: improving the lives of mothers, babies, and patients by translating science into care.

We focus on the personality and professional skills of our candidates. We reject any form of discrimination and look forward to receiving your application.

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