Quality Engineer (Junior) – Praca – Poznań, Sady

Lina Medical; Poznań; Hybrid; PLN 90,000 - 140,000; Full time

Benefits offered by this job

Private medical care

Sports card

Flexible working time

Job summary

Lina Medical in Poznań is seeking a QA/QC Auditor to support non-conforming goods management, testing, QC inspections, and documentation within a medical devices environment.

You will drive CAPA, NC, CR processes, audits, and supplier/purchasing specs, ensure ISO 9001/13485, FDA, and MDD familiarity, and contribute to KPI reporting in an international team.

Qualifications

• Engineer Diploma is required.
• Experience in medical devices/auditing is welcome.
• Fluent in English (spoken and written).
• Familiar with ISO 9001, ISO 13485, FDA, MDD.

Responsibilities

• Support in solving non-conforming goods: overviews, counting, journals in ERP.
• Support in testing and sampling process.
• QC inspection (incoming, in-process, outgoing, final after sterilization) and its documentation.
• DHR/Purchase specification completion and review.
• Create documents according to procedures.
• Implement CAPA actions within the facility.
• Participate in quality-related processes: NC, CAPA, CR.
• Oversee non-conforming goods from quarantine to after-claims activities.
• Update/create GQS (D4) documents within responsibilities.

Skills

Fluent English

Auditing

Quality systems knowledge

Education

Engineer Diploma

Job description

Main responsibilities:

• Support in solving non-conforming goods ? overviews, counting, journals in the ERP system
• Support in testing and sampling process
• QC inspection (incoming, in-process, outgoing, final after sterilization) and its documenting
• DHR/ Purchase specification completion and review
• Creating documents according to existing procedures
• Implementing corrective and preventive actions within the facility
• Participation in all quality related processes: NC, CAPA, CR
• Overview of the non-conforming goods process covers quarantine, claims and after claims activities
• GQS (D4) ? updating/creating the documents within the range of responsibilities
• Internal Auditor for ISO 13485
• Follow and report defined KPIs

Requirements:

• Engineer Diploma is necessary
• Experience from a similar position within Medical Devices Industry is welcome
• Fluent in English ? verbal and written
• Familiar with ISO 9001, ISO 13485, FDA, MDD
• Experience in auditing is an advantage
• Fast learning and open minded
• Efficient, accurate, work according to plan
• Positive & problem-solving attitude

We offer:

• Full-time job contract
• Opportunity to work in an international environment
• A number of benefits (private medical care, sports card, flexible working time)
• Great atmosphere in the office and interesting challenges
• Opportunity to grow with the organization and build a successful career path
• Internal and external training