Customer Complaint Specialist

LiNA Medical ApS; Poznań; On-site; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Private medical care

Sports card

Flexible working time

Home Office

Co-financing for English language classes

Fruit and snacks

Job summary

A leading medical device company in Poland is looking for a quality-focused professional to manage customer complaints and ensure compliance with regulatory standards. You will oversee complaint handling processes, collaborate with various teams, and lead quality initiatives. Ideal candidates should possess a relevant degree, have experience in quality management, and a strong problem-solving attitude. This role offers a full-time contract and various benefits in a supportive environment.

Qualifications

• Minimum 2 years of experience in a similar position.
• Familiarity with ISO 13485 or ISO 9001 standards.
• Experience with quality tools and methodologies.
• Familiarity with ISO 13485 or ISO 9001 standards.
• Experience with quality tools (e.g., 5 Whys, Ishikawa Diagram, 8D Report).
• Proficiency in MS Office (PowerPoint, Excel).
• English proficiency at B2 level or higher.
• Assertiveness and a solution-oriented approach.
• Strong communication and problem-solving skills.
• Experience in the medical device industry is a plus.
• Knowledge of MDR and FDA requirements is a plus.

Responsibilities

• Register and manage customer complaints in a timely manner.
• Oversee the entire complaint-handling process.
• Report incidents to relevant regulatory authorities.
• Continuously monitor and analyze market requirements related to trend reporting and regulatory expectations.
• Update internal procedures and reporting processes in response to regulatory changes.
• Monitor key complaint management indicators and prepare statistical reports.
• Supervise trend reporting processes to identify recurring issues and potential risks.
• Act as the primary contact for distributors and regulatory authorities regarding complaints and medical incidents.
• Collaborate with engineering, production, and quality control teams to investigate complaint root causes.
• Lead the complaint management team—facilitate root cause analysis meetings and define corrective actions.
• Participate in CAPA processes, including initiating CAPAs based on complaint trends.
• Align complaint handling with risk management processes and trigger risk analysis updates when necessary.

Skills

Attention to detail

Problem-solving skills

Communication skills

Assertiveness

English proficiency

Assertiveness

Regulatory knowledge

Education

University degree in Quality Management, Engineering, or related

Tools

MS Office (PowerPoint, Excel)

Job description

Responsibilities

• Register and manage customer complaints in a timely and accurate manner.
• Oversee the entire complaint-handling process—from registration, classification, root cause investigation, corrective action definition, final reporting.
• Report incidents to relevant regulatory authorities worldwide.
• Continuously monitor and analyze market requirements related to trend reporting and regulatory expectations.
• Update internal procedures and reporting processes in response to regulatory changes.
• Monitor key complaint management indicators and prepare statistical reports.
• Supervise trend reporting processes to identify recurring issues and potential risks.
• Act as the primary contact for distributors and regulatory authorities regarding complaints and medical incidents.
• Collaborate closely with engineering, production, and quality control teams to investigate complaint root causes.
• Lead the complaint management team—facilitate root cause analysis meetings and define corrective actions.
• Participate in the Corrective and Preventive Actions (CAPA) process, including initiating CAPAs based on complaint trends.
• Align complaint handling with risk management processes. Trigger risk analysis updates when necessary.

Our requirements:

• University degree in Quality Management, Engineering, or related
• Minimum 2 years of experience in a similar position.
• Strong quality mindset and attention to detail.
• Familiarity with ISO 13485 or ISO 9001 standards.
• Experience with quality tools and methodologies (e.g., 5 Whys, Ishikawa Diagram, 8D Report).
• Proficiency in MS Office (PowerPoint, Excel)
• English proficiency at B2 level or higher.
• Assertiveness and a positive, solution-oriented approach.
• Strong communication and problem-solving skills.
• Experience in the medical device industry is a plus
• Knowledge of Medical Device Regulation (MDR) and FDA requirements is a plus.

We offer:

• Full-time job contract;
• Opportunity to work in an international environment;
• A number of benefits (private medical care, sports card, MyBenefit cafeteria system, flexible working time, Home Office, co-financing for English language classes, fruit and snacks);
• Great atmosphere in the office and interesting challenges;
• Opportunity to grow with the organization and build a successful career path;