Quality Engineering S

Quality Engineer II

Manufacturing

Exciting Quality Engineer II development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care

Quality Engineer II

Contract: 12 month Contract with extension or conversion potential

Benefits : Medical, Dental, Holiday, PTO 401K matching

Quality Engineer – Medical Devices

Provide hands-on quality engineering support for new product development and design changes for instrumentation products. Partner with R&D, Regulatory, and cross-functional teams throughout the product development lifecycle.

Support design controls, risk management, verification/validation, change control, and product transfer.

Review and approve design control, risk management, V&V, and development documentation.

Provide quality guidance and risk-based decision support to development teams.

Assess product and process changes for quality and regulatory impact.

Support deviation investigations, root cause analysis, and CAPA activities.

Ensure compliance with ISO 13485, ISO 14971, GxP, SOPs, and applicable regulatory requirements.

Bachelor’s degree in Engineering, Life Sciences, or related technical field.

• 2+ years of Quality Engineering experience in the medical device industry.
• Experience with design controls, risk management, change control, and V&V.
• Working knowledge of ISO 13485, ISO 14971, and medical device quality systems.
• Candidates must be authorized to work in the United States on a permanent basis.

Sponsorship (including H-1B, OPT, CPT, etc.) We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.