Supplier Quality Engineer (SQE)

About the role

LiNA Medical Polska, a manufacturer of minimally invasive gynaecological medical devices, is looking for a Supplier Quality Engineer (SQE) in Poznań. The SQE ensures that external suppliers meet quality standards and regulatory requirements for materials, components and services used in medical device production, helping to keep the supply chain reliable and the products safe and effective. The recruitment has ended and this is an archived listing.

Key responsibilities

• Evaluate potential suppliers and conduct supplier assessments against quality and regulatory requirements.
• Develop and maintain supplier quality agreements covering standards, responsibilities and expectations.
• Lead parts qualification, including material qualification and validation of incoming components.
• Review and approve supplier documentation such as quality plans, process validation, control plans, risk analyses, certificates of analysis and inspection records.
• Perform supplier audits and assessments of quality management systems and regulatory compliance.
• Monitor supplier performance by KPIs and quality metrics, and address deviations and non-conformities.
• Work with suppliers on corrective and preventive actions (CAPA) and provide technical guidance on quality and regulatory compliance.
• Take part in new product development to assess supplier capabilities and qualify new suppliers.

Required profile

• Bachelor's degree in engineering, quality management or a related field.
• Previous experience in supplier quality management, quality assurance or a related field within the medical device industry.
• Experience conducting supplier audits, assessments and evaluations.
• Excellent communication, negotiation and interpersonal skills.
• Ability to analyse data, identify trends and drive continuous improvement.
• Detail-oriented, with a commitment to accuracy and compliance.

Required skills

• Quality management systems and regulatory requirements such as ISO 13485 and FDA regulations.
• Industry standards such as ISO 14971 and ISO 9001.

What we offer

• Full-time job contract.
• International working environment and internal and external training.
• Benefits including private medical care, sports card, flexible working hours, home office, holiday co-financing, English language course co-financing, fruit and snacks.
• A supportive office atmosphere and opportunities for career growth.