Beschreibung

* Contribute to life-changing healthcare technologies that improve patient outcome
* Join an innovative international environment with strong quality

## About Our Client ##

Our client is an innovative medical technology company dedicated to developing breakthrough solutions that improve the lives of people facing significant health challenges. They foster a collaborative, mission-driven culture where innovation, quality, and patient impact are at the heart of everything they do.

## Job Description ##

* Collaborate with contract manufacturers and suppliers to ensure quality requirements are met throughout the product lifecycle.
* Review and approve manufacturing batch records to ensure compliance with specifications, GMP requirements, and internal procedures.
* Support incoming inspection activities, including review of Certificates of Analysis, inspection reports, and material certifications.
* Assist with material disposition decisions and drive resolution of quality-related discrepancies.
* Participate in nonconformance investigations, root cause analysis, and CAPA implementation.
* Support equipment qualification and process validation activities (IQ/OQ/PQ) at supplier and manufacturing partner sites.
* Support or lead batch release activities, including Device History Record reviews and verification of quality control results.
* Work closely with Regulatory Affairs, Procurement, Manufacturing, and other cross-functional teams to ensure timely issue resolution and product release.
* Participate in supplier audits, quality assessments, and continuous improvement initiatives.
* Ensure compliance with ISO 13485, FDA regulations, MDR requirements, and company quality processes.
* Maintain accurate quality documentation and records according to established procedures and retention requirements.





## The Successful Applicant ##

* Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
* 3-5 years of experience in Quality Assurance within the medical device, pharmaceutical, or another regulated industry.
* Strong knowledge of ISO 13485, FDA QSR, and GxP regulations.
* Experience working with external suppliers and CMOs.
* Familiarity with batch record review and product release processes.
* Experience managing nonconformances, CAPAs, and quality investigations.
* Understanding of equipment qualification, process validation, and risk-based quality approaches.
* Strong analytical, problem-solving, and decision-making abilities.
* Excellent communication and stakeholder management skills.
* Experience using electronic Quality Management Systems such as MasterControl, TrackWise, Veeva, or similar platforms.
* Ability to work effectively in a cross-functional and international environment.





## What's on Offer ##

* Opportunity to make a meaningful impact within an innovative and fast-growing medical technology environment.
* Exposure to cutting-edge products, international suppliers, and complex quality operations.
* Collaborative culture offering responsibilities and autonomy.





Quote job ref

JN-072026-7053979

Job Function

Healthcare & Life Sciences

Specialisation

Medical devices

Industry

Healthcare / Pharmaceutical

Location

Lausanne Region

Contract Type

Interim

Job Reference

JN-072026-7053979