About this role
About the Role Join Getinge as a Quality Engineer at Maquet Suzhou to help ensure regulatory and quality compliance across product history records, release, non-conformity handling, audits, and transfers. What You'll Do
- Collect and review device history records (DHR/batch records) and ensure their integrity, accuracy, and compliance with quality requirements.
- Responsible for product release.
- Involved in non-conformity review processes, with focus on evaluating non-conformities impacting finished products, and support quality hold and disposition for products released from the factory but not yet delivered to customers.
- Participate in the development, review, and tracking of master plans for product process validation/verification, ensuring activities comply with quality systems and regulatory requirements.
- Act as an internal auditor to participate in quality system and process audits, prepare audit reports, and follow up on audit findings and corrective actions.
- Involved in new product transfer projects and responsible for QA-related activities in project transfers.
- Complete temporary matters entrusted by the Quality Manager or QA supervisor. What We're Looking For
- Bachelor’s degree or above in Mechanical Engineering, Medical Device, or related field.
- Minimum 3 years of quality control experience in manufacturing; GMP experience in the medical industry is preferable.
- Basic English communication, reading, and writing skills.
- Familiar with ISO 13485 and 21 CFR 820, and the Medical Device GMP requirements (Chinese GMP) in practice.
- Familiar with quality tools and basic statistical methods (e.g., SPC).