Senior Quality & Risk Engineer, Medical Devices

Werfenlife SA.; Norcross (GA); On-site; USD 80,000 - 110,000; Full time

Job summary

Werfenlife SA. is seeking a Sr. Quality Assurance Engineer to apply engineering and quality principles to medical devices under EU and FDA regulations. Responsible for risk management and design controls, the role collaborates with R&D and other functions to ensure product compliance.

The ideal candidate has at least 5 years in medical devices, preferably in IVD, and a Bachelor’s degree in Engineering or related discipline. Quality certifications are a plus. This role is located in Norcross, Georgia.

Qualifications

• Minimum 5 years of medical device experience in Quality or R&D Engineering.
• Experience in IVD industry preferred.
• Quality certifications such as CQE, CQA, ASQ, or SSBB preferred.

Responsibilities

• Lead risk management initiatives throughout the product lifecycle.
• Manage new risk assessments and collaborate with stakeholders.
• Review design and process changes to ensure compliance.

Skills

Risk management

Design control

Regulatory compliance

Collaboration

Microsoft Office proficiency

Education

Bachelor’s degree in Engineering or related scientific discipline

Tools

ISO 14971

Job description

Werfenlife SA. is seeking a Sr. Quality Assurance Engineer to apply engineering and quality principles to medical devices under EU and FDA regulations. Responsible for risk management and design controls, the role collaborates with R&D and other functions to ensure product compliance.

The ideal candidate has at least 5 years in medical devices, preferably in IVD, and a Bachelor’s degree in Engineering or related discipline. Quality certifications are a plus. This role is located in Norcross, Georgia.