Jobs

Description

Assignment Duration: 6 months

Shift Hours: 8:30-5pm

Required Education:

• Requires a bachelor's degree in Engineering, Quality Assurance, or a related field

• Proven ability to investigate and resolve quality issues, including Nonconforming Events (NCEs) and CAPAs, through root cause analysis and sustainable corrective actions.

Position Summary

• Quality Engineer ensures Client’s medical device (capital equipment) manufacturing operations meets the highest quality standards by supporting manufacturing quality control and regulatory compliance. Collaborating across teams, this role drives continuous improvement, maintains robust process controls, and delivers innovative solutions that uphold product quality, safety, and reliability.

Essential Duties and Responsibilities

• The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

• This role will focus on supporting daily operations quality needs, such as: nonconforming event (NCE) investigations and rework approvals; equipment record review / out of tolerance investigations; containment / investigation of emerging issues in production, incoming inspection, and final release; and operational excellence activities.

Qualifications : Education

• Bachelor’s Degree in Engineering or related discipline, or equivalent combination of education and experience.

Experience

• 2-4 years of experience as a Quality Professional in the Medical Device industry, or equivalent combination of education and experience.
• Experience with Class II and III Medical Device and/or IVD Device Capital Equipment is a plus. 

Skills

• Strong knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP, with the ability to ensure compliance and product quality.
• Proven ability to investigate and resolve quality issues, including Nonconforming Events (NCEs) and CAPAs, through root cause analysis and sustainable corrective actions.
• Clear understanding in risk management principles, including ISO 14971 and pFMEA, to support design transfer and production processes.