You will support the quality management system of Medela's "Essentials" product portfolio, focusing on quality aspects and process implementation.
Your goal is to drive continuous improvement of processes and verify manufacturing processes by working with internal stakeholders, customers, and suppliers daily to ensure high product quality delivery.
Key Responsibilities
* Support document control, reviewing, and archival of documents for the quality function.
* Update quality records in respective storage locations, including technical files, supplier files, electronic quality handbook, and archiving.
* Assist with change management activities through initiation of change controls and maintenance of the change register.
* Plan and execute verification activities for manufacturing processes supporting product implementation.
* Initiate investigations, investigate, and implement Corrective Action Preventive Action (CAPA) and verify effectiveness.
* Manage suppliers, plan, execute supplier audits according to audit programs, and follow up on supplier corrective action requests.
* Contribute to new product introductions with quality-related activities during design transfer, manufacturing line setup, and other relevant phases.
Requirements
* Bachelor's degree or equivalent in a relevant technical discipline.
* At least 3 years of experience in quality assurance, preferably in a manufacturing environment.
* Knowledge of ISO 9001 Quality Management System (QMS), experience working with QMS for medical and non-medical products.
* Familiarity with CAPA, continuous improvement, problem-solving, 5S, risk assessment, conducting internal audits, and supplier audits (onsite and remote).
* Fluent written and spoken English and German, combined with excellent communication skills.
* Desirable: knowledge of regulatory aspects related to cosmetic and medical device products.
* Availability to start immediately, motivated to cover a team member's maternity leave for approximately 9 months.
What We Offer
* A culture of inclusivity and respect that values and supports every team member, as part of the Medela Family.
* Flexibility: option to work in a hybrid model with up to 3 days per week from home.
* Growth Opportunities: various learning initiatives both on and off the job.
* Competitive package: benefits aligned with international benchmarks, including extended parental leave, insurance, additional vacation or bridge days.
* Balance: range of activities promoting health and well-being.