Quality Assurance Lead – QMS & CAPA

Lincotek Group; Busano; On-site; EUR 42,000 - 60,000; Full time

Job summary

Lincotek Group is seeking a Quality Assurance Specialist to develop and maintain the QMS across manufacturing processes. You will collaborate with Top Management and across plant departments to ensure compliance with ISO 13485 and other medical device standards.

Responsibilities include leading internal and supplier audits, managing CAPA, coordinating documentation for audits, and driving continuous quality improvement with cross-functional teams.

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Physics, Chemistry, Engineering) or High School Diploma.
• 3+ years of relevant experience.
• Excellent command of English and Italian (both written and spoken).

Responsibilities

• QMS: Maintain and manage the QMS to ensure manufacturing processes meet regulatory standards and customer requirements.
• Non-Conformity & CAPA: Manage non-conformity processes along with corrective and preventive actions.
• Documentation & Compliance: Coordinate quality documentation for regulatory activities and audits with a risk-based approach.
• Internal Audits: Plan and conduct internal audits.
• Subcontractor Audits: Audit subcontractor facilities and external laboratories.
• Training Program: Define and implement the quality training program with Top Management.
• Customer Complaints & Issue Resolution: Manage non-conformities and preventive actions.
• Quality Plans: Review and approve quality plans with clients/suppliers.
• Procedures & Instructions: Review and approve procedures and work instructions.
• KPI Analysis: Analyze KPI trends to evaluate quality performance.
• Continuous Improvement: Identify issues and propose effective solutions.
• Product Release: Define release flows in line with medical device regulations.
• Scrap & Defect Management: Define workflows for scrap management and defect reporting.

Skills

Lab analysis

NDT

Metrology

Statistical data analysis

Regulatory knowledge

Quality management systems

Education

Bachelor’s degree in scientific discipline

High School Diploma

Job description

Lincotek Group is seeking a Quality Assurance Specialist to develop and maintain the QMS across manufacturing processes. You will collaborate with Top Management and across plant departments to ensure compliance with ISO 13485 and other medical device standards.

Responsibilities include leading internal and supplier audits, managing CAPA, coordinating documentation for audits, and driving continuous quality improvement with cross-functional teams.