Senior Quality Engineer — PLM Systems & Compliance

Planet Pharma; North Haven (CT); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading healthcare company in North Haven, CT, is looking for a Senior Quality Engineer to support the transition to a new PLM system while ensuring compliance with quality standards. This role involves collaboration with cross-functional teams, reviewing workflows, and maintaining quality operations during the transition. Candidates should have 5-7 years of relevant experience and a degree in Engineering or Science. The position offers a chance to work independently and lead projects ensuring robust quality system integration.

Qualifications

• 5-7 years of experience in quality engineering, flexible based on work history.
• Advanced knowledge of medical device quality systems.
• Experience with PLM or electronic quality systems.

Responsibilities

• Develop quality standards and protocols for processing materials.
• Collaborate with engineering and manufacturing to ensure quality.
• Implement inspection and testing methods for products.
• Conduct quality assurance tests and statistical analysis.
• Ensure corrective measures meet reliability standards.
• Support site transition to a new PLM system.

Skills

Quality Systems & Change Management

PLM / Digital Quality Systems Implementation

Cross-Functional Quality Execution

Education

BS in Engineering or Science

Job description

A leading healthcare company in North Haven, CT, is looking for a Senior Quality Engineer to support the transition to a new PLM system while ensuring compliance with quality standards. This role involves collaboration with cross-functional teams, reviewing workflows, and maintaining quality operations during the transition. Candidates should have 5-7 years of relevant experience and a degree in Engineering or Science. The position offers a chance to work independently and lead projects ensuring robust quality system integration.