Quality Engineer II - Medical Devices

About the role

This role supports the development and manufacturing of existing and new medical devices, working with Manufacturing and R&D to resolve product quality issues, including field complaints. It covers process changes, product design improvements and the implementation of new products.

Key responsibilities

• Review process changes with manufacturing engineers, resolve quality issues and assess related risks
• Work with suppliers to maintain high quality of incoming materials and take part in supplier quality audits when required
• Support new product implementation by reviewing quality and testing plans with R&D engineers
• Help develop FMEAs, test protocols and reports (design verification, design validation, process qualification and validation)
• Maintain quality systems such as CAPA, non-conformance, supplier quality, equipment calibration, internal auditing and quality metrics data analysis
• Comply with laws and regulations and quality management system requirements, and perform additional duties as assigned

Required profile

• Bachelor's degree in engineering or a related field
• At least 3 years of related medical device manufacturing experience
• Intermediate computer skills and knowledge of MS Office (Word, Excel, PowerPoint, Teams, Outlook)
• English level B1 or above
• Ability to read and interpret PFMEA risk assessments, validation processes (TM/VQPs, VQRs) and production controls
• At least 1 year of root cause analysis experience (Fishbone); 1 year of hands-on nonconforming product handling experience
• Strong written and verbal communication skills

Required skills

• Desired: basic knowledge of ISO 13485 and familiarity with medical device quality systems
• Desired: statistical software (Minitab, Stratigraphic, DOE)
• Desired: complaint handling, risk management (ISO 14971) and quality assurance basics

To apply, send your updated English resume to the recruiter named in the posting.