Quality Assurance Specialist

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

Job summary

Intervieweb is seeking a Quality Assurance Specialist to develop and maintain our Quality Management System (QMS) and work closely with Top Management to ensure regulatory compliance. You will lead CAPA processes, coordinate documentation for audits, and drive continuous improvement across all plant departments.

The role involves planning internal and supplier audits, defining training programs, and managing product release flows in line with medical device regulations.

Qualifications

• Experience maintaining and improving a QMS in a regulated industry.
• Strong CAPA and non-conformity resolution skills.
• Ability to plan and conduct internal and supplier audits.
• Experience coordinating documentation for regulatory activities and audits.
• Knowledge of medical device regulations and product release workflows.

Responsibilities

• Maintain and manage the QMS to ensure compliance with regulatory standards and customer requirements.
• Manage Non-Conformity processes along with CAPA.
• Coordinate quality documentation for regulatory activities and audits using a risk-based approach.
• Plan and perform internal audits.
• Conduct audits at subcontractor facilities and external laboratories.
• Define and implement the quality training program for personnel involved in service quality.
• Manage customer complaints and preventive actions.
• Review and approve quality plans with clients and suppliers of outsourced processes.
• Review and approve procedures and work instructions.
• Manage KPI trend analysis to evaluate quality performance.
• Identify issues and drive continuous improvements.
• Define and implement product release flows in compliance with medical device regulations.
• Define and manage scrap and defect workflows in line with medical standards.

Skills

QMS management

CAPA

Internal audits

Regulatory compliance

Documentation

Training program design

KPI analysis

Continuous improvement

Supplier/audits

Education

Bachelor's degree in Quality Assurance or related field

Job description

ABOUT THE JOB

The Quality Assurance Specialist is responsible for developing and maintaining the company’s Quality Management System (QMS). Working closely with Top Management, this role reports directly to the Site Quality Manager and collaborates cross-functionally across all plant departments.

MAIN RESPONSIBILITIES

• QMS Management: Maintain and manage the QMS to ensure all manufacturing processes and services supplied by Lincotek comply with regulatory standards and customer contractual requirements.
• Non-Conformity & CAPA: Manage Non-Conformity processes along with Corrective and Preventive Actions (CAPA).
• Documentation & Compliance: Coordinate the preparation of quality documentation required for regulatory activities and certification audits, applying a risk-based approach across the entire QMS.
• Internal Audits: Plan and execute internal audits.
• Subcontractor Audits: Conduct audits at subcontractor facilities, including external laboratories.
• Training Program: Define and implement, in collaboration with Top Management, the quality training program for all personnel involved in activities impacting service quality.
• Customer Complaints & Issue Resolution: Manage non-conformities, customer complaints, and preventive actions.
• Quality Plans: Review, prepare, and approve quality plans with clients and suppliers of outsourced services/processes.
• Procedures & Instructions: Review and approve procedures and work instructions.
• KPI Analysis: Manage KPI trend analysis to evaluate overall quality performance.
• Continuous Improvement: Identify quality issues or areas for improvement and propose effective solutions.
• Product Release: Define and implement product release flows (including issuing release documentation) in compliance with applicable medical device regulations.
• Scrap & Defect Management: Define and manage workflows for scrap management and defect reporting, ensuring full compliance with medical standards.

SUPERVISORY RESPONSIBILITY

none