Quality Technician

• 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 Gx P 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 Master Control, Track Wise, 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.
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