Quality Engineer

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

Core Responsibilities

• Establish and maintain master validation program, including site and individual products and process master validations
• Create/Review/Support validation protocols and reports to support process and reliability improvements
• Support complaint handling program, including complaint analysis, investigation, and follow up
• Lead and/or support reliability and process improvements projects from quality perspective
• Establish and maintain process controls/SPC for specific production processes
• Support corrective and preventive action (CAPA) program
• Review and modify product designs and process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements
• Demonstrate product compliance for sterilization, biocompatibility, package integrity, shelf life, reliability, and electrical safety
• Review and provide feedback of protocols and reports, test vendor qualification, and testing management
• Assist with the development and maintenance of product risk management files
• Assist with design verification testing and test method assessment and validation activities
• Recommend requirements for first article inspection, incoming and in-process inspections, and lot releae testing, including sampling strategy and test methods
• Participate in failure investigations to analyze internal system or process failures and to implement corrective and preventive action
• Participate in component and service new supplier evaluation. Works with suppliers to ensure appropriate quality controls are implemented
• Audit Design History Files and works with cross functional team to resolve documentation issues
• Identify and implement good quality engineering practices, including statistical methods and root cause analysis tools
• Participate in supplier material related processes which include coordination of MRB activities to ensure the timely assessment of potential non-conforming products
• Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develop, and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions
• Demonstrate the ability to implement ISO 14971, including risk evaluation techniques

QUALIFICATIONS (Education, Experience, Certifications)

• Bachelor's degree preferably in an engineering or scientific discipline from a four-year college or university
• 5+ years related experience and/or training; or equivalent combination of education and experience
• Medical Device or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military or nuclear
• A working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, ISO10993,ISO 11135, and the EU Medical Device Directive is a plus
• Familiarity with test methods and standards for the design, verification, and validation of medical device products is required
• Experience with PPAP, PMEA.