Quality Engineer – Medical Devices, Validation & Improvement

Pentangle Tech Services | P5 Group; North Haven (CT); On-site; USD 85,000 - 105,000; Full time

Job summary

Pentangle Tech Services | P5 Group is seeking a qualified Quality Assurance professional to establish and maintain the master validation program for site and product lines. The role includes creating and reviewing validation protocols, supporting complaint handling, and driving continuous quality improvements across processes.

You will lead CAPA activities, maintain process controls, and assist with design verification and risk management files to ensure compliance with medical device quality

Qualifications

• Bachelor's degree in engineering or science from a four-year college or university.
• Experience in medical device quality or regulated industries preferred.
• Working knowledge of FDA QSR, ISO 13485, ISO 14971, ISO 11135 and EU Medical Device Directive is a plus.
• Familiarity with PPAP, CAPA and risk-based quality practices.

Responsibilities

• Establish and maintain master validation program for site and products.
• Create/review/test/validate protocols and reports supporting improvements.
• Support complaint handling including analysis, investigation and follow-up.
• Lead quality projects and implement SPC controls for production processes.
• Contribute to CAPA, document control reviews, and risk management files.
• Assist with design verification testing and test method validation.

Skills

Quality engineering

Root cause analysis

Statistical methods

Risk management

Supplier quality

Education

Bachelor's degree in engineering or science

Tools

PPAP

CAPA

ISO 14971

FDA QSR familiarity

Job description

Pentangle Tech Services | P5 Group is seeking a qualified Quality Assurance professional to establish and maintain the master validation program for site and product lines. The role includes creating and reviewing validation protocols, supporting complaint handling, and driving continuous quality improvements across processes.

You will lead CAPA activities, maintain process controls, and assist with design verification and risk management files to ensure compliance with medical device quality