What are the responsibilities and job description for the Senior Quality Engineer position at ATR International?
Our client is seeking a Senior Quality Engineer to support new product development in the Surgical Instruments division. The role is a key member of the Quality team, working closely with cross-functional partners to ensure product quality, regulatory compliance, and continuous improvement.
Key Responsibilities
- Partner with R&D to define and execute design verification & validation testing
- Lead and support risk management activities (Hazard Analysis, DFMEA, UFMEA, complaint analysis)
- Contribute to design and process validation planning and execution
- Collect and analyze data, prepare reports, and provide recommendations
- Solve complex quality and process challenges independently
Qualifications
- Bachelor’s degree in Engineering (or related field)
- 4 years’ experience in Quality or Engineering (regulated industry preferred)
- Strong skills in risk management, design verification, and NPD quality tools
- Proficiency with Minitab/statistical analysis and knowledge of ISO 13485
Preferred
- ASQ Certified Quality Engineer (CQE)
- Experience with medical device standards (ISO 13485, ISO 14971, IEC 60601)
- Understanding of software/hardware interfaces
Top 3 Skills Required
- Risk Management (Hazard Analysis, DFMEA, UFMEA)
- Design Verification Authoring & Execution
- General NPD Quality Engineering (Change Control, CAPA, ISO 13485)
Salary : $55 - $65
