Impactful Quality Engineer II - Med Devices QA & Compliance

Laborie; Portsmouth (NH); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Paid time off and paid volunteer time

Medical, Dental, Vision and Flexible F

Health Savings Account with Company'}}

Company Funded Contributions

Job summary

Laborie in Portsmouth, NH is seeking a Quality Engineer II to ensure product and process conformity to requirements. You will document quality systems, support operations, R&D, and contract manufacturers while upholding FDA QSR and ISO 13485 standards.

The role emphasizes investigations, CAPA, audits, and risk assessments, with opportunities to lead cross-functional projects and improve patient outcomes in a global medical device company.

Qualifications

• At least 5 years engineering experience in a regulated field.
• B.S. in engineering or science.
• Strong knowledge of FDA QSR and ISO 13485 requirements.
• Critical thinking and sound decision-making skills.
• Excellent written and verbal communication skills.
• Ability to independently solve problems, lead projects and influence teams.
• Demonstrated ability to work as a team player with multi-disciplinary project teams.
• Demonstrated ability to interpret technical information.
• Experience with quality audits (lead auditor certification preferred).
• ASQ certification preferred.
• Lean Six Sigma training preferred.

Responsibilities

• Establish and maintain documentation for the inspection and release of raw materials, sub-assemblies and finished medical devices
• Perform quality activities in support of Operations, contract manufacturers and R&D
• Schedule and document calibration and maintenance activities
• Support design and engineering change processes and associated documentation
• Support internal and external audit activities and work to resolve audit nonconformities.
• Perform and support process, equipment validations.
• Investigate, disposition and close nonconformities.
• Investigate and close product complaints.
• Collect and evaluate quality data for process monitoring, management review and post market surveillance
• Perform quality activities related to CAPA processes
• Represent Quality Engineering in the development and maintenance of process and product risk assessments (e.g.pFMEAsdFMEA)
• Participate in Material Review Board reviews including material segregation, investigation,correctionsand dispositions

Skills

Critical thinking

Problem solving

Communication skills

Team collaboration

Independent work

Education

B.S. in engineering or science

Lean Six Sigma training preferred

ASQ certification preferred

Job description

Laborie in Portsmouth, NH is seeking a Quality Engineer II to ensure product and process conformity to requirements. You will document quality systems, support operations, R&D, and contract manufacturers while upholding FDA QSR and ISO 13485 standards.

The role emphasizes investigations, CAPA, audits, and risk assessments, with opportunities to lead cross-functional projects and improve patient outcomes in a global medical device company.