Supplier Quality Engineer

• Global company in the medical sector
• Jelcz

O naszym kliencie

Our client is a company operating in the life science sector. They are a well-established organisation with a commitment to innovation and maintaining high-quality standards in their products and services.

Opis stanowiska

• Assess, qualify, and provide support to procurement activities related to onboarding new suppliers, particularly in the area of medical devices and pharmaceutical packaging components (e.g., plastics, films, foils, labels, cartons, and sterile packaging systems).
• Execute supplier audits (both on-site and remote) to verify alignment with ISO 13485, ISO 9001, GMP standards, and relevant regulatory frameworks.
• Work closely with the Purchasing team to maintain and update the Approved Vendor List (AVL), ensuring that all supplier-related documentation (e.g., quality agreements, certifications, validation files) remains current and compliant.
• Contribute to supplier onboarding processes, including risk assessments using tools such as FMEA and risk-based qualification approaches.
• Ensure that supplier materials and processes meet all applicable regulatory requirements, including FDA (21 CFR Part 820/211), EU MDR, ISO 11607, and other relevant standards.
• Liaise with suppliers to collect and validate declarations on material composition and confirm compliance with EU MDR 2017/745 regarding restricted substances.
• Conduct regular evaluations of supplier performance and prepare summary reports for management review.
• Support the development of incoming inspection strategies, including sampling plans and material specifications.
• Manage supplier nonconformance cases by issuing reports, leading root cause investigations, and driving corrective and preventive actions (CAPA).
• Contribute to initiatives aimed at minimizing supplier-related quality issues.
• Collaborate with Engineering and Supply Chain teams to implement continuous improvement initiatives, focusing on process optimization and risk reduction.
• Ensure adherence to GMP requirements, including proper process controls and validation activities.
• Organize supplier review meetings, provide feedback, and prepare performance reports, dashboards, and inputs for management reviews.
• Support procurement in supplier selection, contract negotiations, and establishment of quality agreements.
• Assist in resolving incoming quality issues by working with suppliers to enhance processes and improve material acceptance rates.
• Carry out additional tasks assigned by the manager and complete them within agreed timelines.

Profil kandydata

• Bachelor's degree in Engineering, Quality Management, Life Sciences, or a related discipline.
• Minimum of 3 to 7 years of experience in supplier quality, quality engineering, or manufacturing quality within medical devices, pharmaceuticals, or highly regulated packaging environments.
• Solid understanding of ISO 13485, GMP, FDA regulations, and/or EU MDR requirements.
• Hands-on experience with supplier audits, CAPA processes, root cause analysis, and risk management methodologies.
• Knowledge of packaging materials (such as plastics, sterile barrier systems, labels, and cartons) and validation processes is considered a strong asset.
• Ability to read and interpret technical drawings, specifications, and validation documentation.
• Proactive mindset with a willingness to learn and take initiative.
• Capable of working both independently and collaboratively with minimal supervision.
• Strong organizational, project management, and leadership skills, with experience leading cross-functional teams and effectively resolving quality-related challenges.
• Familiarity with continuous improvement methodologies such as Six Sigma or Lean Manufacturing.
• Fluency in English, both written and spoken.

Oferujemy

• Comprehensive benefits package, including a Multisport card and medical package.
• Opportunities to work in the life science industry with a focus on quality and innovation.
• A collaborative work environment in a medium-sized organisation.
• Professional development opportunities in engineering and manufacturing.