QA/QC Manager, Medical Devices & Regulatory Lead

Wideandwise; Fatih; On-site; TRY 650,000 - 900,000; Full time

Job summary

Wideandwise is seeking a hands-on QA/QC Manager to own ISO 13485 QMS, regulatory compliance, and production quality control in a medical device manufacturing environment. You will lead EU MDR CE certification efforts, author technical documentation, and drive robust QC across all manufacturing steps.

The role requires 5+ years in QA/RA within medical devices, deep ISO 13485 experience, and English proficiency. Master’s degree is a plus; PRRC exposure is desirable in a scale-up setting.

Qualifications

• 5+ years of hands-on Quality Assurance / Regulatory Affairs experience within the medical device manufacturing industry.
• In-depth knowledge of ISO 13485:2016 and EU MDR (2017/745).
• Experience drafting technical files, managing GSPR, and leading Notified Body audits for Class IIa or higher devices.
• Hands-on, independent authoring of procedures, validation protocols, and floor-level QC.
• Fluent English (written and spoken).
• Nice to have ISO 13485 Lead Auditor certification or PRRC background.

Responsibilities

• Establish, maintain, and improve ISO 13485 QMS tailored to Class IIa medical devices.
• Lead EU MDR CE certification efforts and manage Notified Body communications.
• Author and coordinate Technical Documentation (Annex II/III) including GSPR and CER.
• Design and oversee QC plans for raw materials, in-process thermoforming, and final packaging; supervise release processes.
• Manage IQ/OQ/PQ, cleanroom controls, and process validations.
• Plan internal and supplier audits; oversee PMS and post-market activities; manage ÜTS/EUDAMED registrations.
• Fulfill PRRC role responsibilities under EU MDR where required.

Skills

Quality Assurance

Regulatory Affairs

Audits

GXP Compliance

Documentation

Education

Bachelor's degree in Engineering or Life Sciences

Master's degree (plus)

Job description

Wideandwise is seeking a hands-on QA/QC Manager to own ISO 13485 QMS, regulatory compliance, and production quality control in a medical device manufacturing environment. You will lead EU MDR CE certification efforts, author technical documentation, and drive robust QC across all manufacturing steps.

The role requires 5+ years in QA/RA within medical devices, deep ISO 13485 experience, and English proficiency. Master’s degree is a plus; PRRC exposure is desirable in a scale-up setting.