Remote MedTech Supplier Quality Engineer - Impact

LiNA Medical ApS; Województwo wielkopolskie; Hybrid; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Private medical care

Sports card

Flexible working time

Home Office

Co-financing of holidays

Co-financing for English language

Fruit and snacks

Job summary

LiNA Medical ApS seeks a Supplier Quality Engineer to ensure external suppliers meet quality and regulatory standards for medical device materials and services. You will lead supplier assessments, develop quality agreements, and oversee qualification activities to ensure safe, effective products.

The role requires strong QMS knowledge, ISO 13485 and FDA familiarity, and excellent communication to drive improvements across the supply chain.

Qualifications

• Bachelor's degree in engineering, quality management, or related field.
• Experience in supplier quality management, quality assurance, or related field within the medical device industry.
• Strong understanding of QMS, regulatory requirements (ISO 13485, FDA), and industry standards (ISO 14971, ISO 9001).
• Experience conducting supplier audits, assessments, and evaluations.
• Excellent communication, negotiation, and interpersonal skills.
• Ability to analyze data, identify trends, and drive continuous improvement initiatives.
• Detail-oriented with a commitment to accuracy and compliance.

Responsibilities

• Evaluate potential suppliers and conduct supplier assessments.
• Develop and maintain supplier quality agreements.
• Lead parts qualification activities and validate incoming components.
• Review and approve supplier documentation (quality plans, process validation, control plans, risk analysis, COAs, inspection records).
• Perform supplier audits and assessments for compliance with QMS and regulatory requirements.
• Monitor supplier performance via KPIs and address deviations.
• Collaborate with suppliers to implement CAPA and drive improvements.
• Provide technical support on quality requirements and regulatory compliance.
• Participate in new product development to assess supplier capability and integration.

Skills

Quality management

Supplier audits

Data analysis

Communication

Education

Bachelor's degree in engineering or quality management

Tools

ISO 13485

FDA regulations

Job description

LiNA Medical ApS seeks a Supplier Quality Engineer to ensure external suppliers meet quality and regulatory standards for medical device materials and services. You will lead supplier assessments, develop quality agreements, and oversee qualification activities to ensure safe, effective products.

The role requires strong QMS knowledge, ISO 13485 and FDA familiarity, and excellent communication to drive improvements across the supply chain.