QA Manager / QA System Engineer

QMS Ownership & Hands-On Operations

QMS Maintenance: Maintain and improve the QMS to ensure full compliance with ISO 13485 and EU /MDR / IVDR / QMSR / ISO 27001

Document Control: Manage the document control process, including Device History Files (DHF) and Device Master Records (DMR).

NC, CAPA & Complaints: Lead investigations for nonconforming products, customer complaints, and Corrective and Preventive Actions (CAPA).

Core Processes: Execute daily activities for change control, deviations, training control.

CRB Chair: Chair the Corrective Action Review Board (CRB) meetings.

Supplier Management: Maintain the Approved Supplier List (ASL), approve new suppliers, manage Supplier Corrective Action Reports (SCARs), and approve Quality Assurance Agreements (QAA).

Executive Oversight: Lead management reviews, facilitate and track QMS objectives, and execute quality plans.

Leading 3rd party Audits: Lead ISO 13485, MDR, IVDR, audits

Production & Operations Support

Product Release: Perform Device History Record (DHR) reviews, approve QC tests, and grant final product release.

Facility Control: Oversee equipment maintenance, calibration activities, and environmental monitoring.

Operational Quality: Initiate, investigate, and approve deviations and Non-Conformances (NCs).

Incoming Goods: Oversee purchasing controls and perform incoming inspections for materials.

Cross-Functional Support

Regulatory Affairs: Support technical documentation maintenance, labeling updates, standards monitoring, Post-Market Surveillance (PMS), and adverse event reporting.

Commercial Support: Review customer orders and assist marketing with technical requests as needed. Support and facilitate feedback process.

Culture: Advocate for QMS compliance and build a strong quality culture across the company.

• Technical or scientific degree
• Minimum 5 years of quality assurance experience in the medical device industry.
• Direct hands-on experience with various EU Classes including IIb or Class III medical devices.
• Ability to switch easily between high-level strategy and daily hands-on tasks
• Proven track record with EU MDR / IVDR and ISO 13485 audits.
• Ability to deliver results.
• Effective communication, collaboration, and flexibility to learn new work environments and relationships with customers.
• Fluent in English.
• Advantage: Experienced as consultant
• Advantage: experienced with sterilization processes Gamma / EtO