Quality Engineer III (Sustaining Engineer)

LanceSoft Inc; Raynham (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical technology firm in Raynham seeks a Quality Engineer III to support design change and business projects in neurosurgery. The ideal candidate will have a Bachelor's in Engineering, 5+ years of experience in the medical device industry, and familiarity with FDA QSR and ISO13485 standards. Responsibilities include collaboration in cross-functional teams and executing risk management processes. A commitment to strong analytical and communication skills is essential. Travel may be required up to 10%.

Qualifications

• Minimum of 5 years of related experience.
• Experience in the medical device industry preferred.
• Knowledge of FDA QSR and ISO13485 requirements.

Responsibilities

• Support design change and base business projects.
• Cross-functional team member for design changes.
• Execute Risk Management processes and tools.

Skills

Analytical skills

Problem-solving

Team collaboration

Communication skills

Education

Bachelor’s Degree in Engineering

Job description

Company Description

JOHNSON & JOHNSON CODMAN

Job Description

Quality Engineer III, Codman Sustaining Engineering

Core Responsibilities

• Sustaining Engineering will support design change and base business projects of varying scope and complexity across the total Codman Business – Neuro Surgery and Neuro Vascular
• Core team member of cross‑functional teams focused on design changes on existing products and base business projects
• Knowledge of Design Controls / Design Change processes
• Knowledge and execution of Risk Management processes and tools
• Strong analytical skills
• Travel up to 10% of the Time

Qualifications

• Bachelor’s Degree required, with preference for Engineering
• Experience in the medical device industry and knowledge in FDA QSR and ISO13485 requirements is preferred
• Minimum of 5 years of related experience

Key Competencies

• Teaming and collaboration, including building strong cross‑functional relationships
• Ability to management multiple projects
• Problem‑solving
• Strong written and verbal communication skills as well as presentation and analytical/statistical skills are required

Additional Information