Quality Assurance Engineer 2

About the role

The Quality Assurance Engineer 2 will provide statistical and technical support to ensure product and process quality in the manufacturing of medical devices. This internal position focuses on continuous improvement, compliance with quality management systems, and resolution of non‑conformities.

Key responsibilities

• Develop and execute statistical plans, sampling plans, dimensional tolerance studies, and inspection methodologies.
• Perform Gauge R&R (GR&R) analyses, validations, qualifications, and technology transfers.
• Manage non‑conformities, including investigation, corrective and preventive actions (CAPA), and quarantine processes.
• Coordinate failure analyses and respond to customer complaints with root‑cause investigations.
• Support continuous improvement initiatives in manufacturing and inspection processes.
• Ensure adherence to manufacturing, packaging, and labeling procedures in line with the quality management system.
• Promote a quality culture and participate in internal and external audits as a Subject Matter Expert.
• Carry out any additional duties assigned by the immediate supervisor.

Required profile

• Internal candidates only (P2 level).
• Strong background in quality engineering or related engineering discipline.
• Familiarity with medical device regulations and quality standards.
• Ability to work collaboratively across manufacturing and quality teams.

Required skills

• Statistical analysis
• Sampling plan development
• Dimensional tolerance analysis
• Inspection methodology
• Gauge R&R (GR&R) analysis
• Validation and qualification procedures
• CAPA management
• Failure analysis
• Internal and external audit support