Overview
Medical Device Quality Engineer Jobs in Scarborough, ME at Collabera
Title: Medical Device Quality Engineer
Company: Collabera
Location: Scarborough, ME
Job Summary:
The Quality Engineer will support medical device quality assurance activities in compliance with regulatory standards and internal quality systems. This role focuses on inspection processes, complaint investigations, and continuous quality improvement initiatives. The position requires collaboration with cross-functional teams and suppliers to ensure product quality and regulatory compliance.
Key Responsibilities:
• Develop and document incoming inspection processes and activities
• Provide in-process quality assurance support including inspection and documentation review
• Perform final product acceptance activities to ensure compliance with specifications
• Manage sterilization processes including validation and sterile load oversight
• Track nonconforming materials and lead material review board activities
• Collaborate with suppliers, contractors, and consultants to ensure component quality
• Lead complaint investigations and perform failure analysis on returned products
• Manage corrective actions and drive continuous quality improvement initiatives
• Support internal quality systems including calibration, inspection, and documentation processes
• Assist with internal quality audits and ensure audit readiness
• Contribute to management review meetings and quality system evaluations
• Establish, monitor, and analyze quality metrics for continuous improvement
Required Qualifications:
• Bachelor’s degree in Engineering or a related technical field
• Experience in medical device quality assurance or regulated industry environment
• Knowledge of quality standards such as ISO 13485 and quality system regulations
• Experience with inspection processes, nonconformance handling, and corrective actions
• Strong analytical, problem-solving, and documentation skills
Preferred Qualifications:
• Experience supporting complaint investigations and failure analysis
• Familiarity with sterilization processes and validation activities
• Experience working with suppliers and quality audits
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.
Pay Range: $40/hr to $45/hr
