Quality Engineer - Hybrid

PURPOSE OF JOB:  2nd-level engineering role at CQG. Primarily responsible for client facing engineering solution development and implementation, and to support day-to-day activities surrounding the operation of the client(s) quality system, supplier QA, design assurance and manufacturing QA throughout the product life cycle. The QE will also provide support for maintenance and implementation of Client Quality Systems. This role may manage projects occasionally and is tasked with leveraging the internal team to maximize efficiency on projects.

MAJOR DUTIES AND RESPONSIBILITIES:

Engineering (50%):

• Ensure design controls in product development and improvement project activities, including risk management, design reviews, tagging/tracing, non-product tools validation, and product/process validation
• Author and/or review design input/output/verification/validation documents as appropriate
• Author and/or review documents for 510(k)s
• Work with R&D on technical File for CE Marking
• Work with R&D on EMC and safety (UL/CSA) certification
• Audit DHF
• Review activities for receiving inspection, device history records, component release and process validation
• Review and approve DMR, DHR, and Validation Protocols and Reports related to processes, equipment, facility and computer systems
• Interface with Operations to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation and training
• Manage the equipment calibration program

Quality Systems (50%):

• Establish and maintain quality assurance programs, processes, procedures and controls to maintain compliance and continual improvement, and to ensure that performance and quality of products conform to established standards
• Manage and conduct internal audits to assure compliance and continual improvement
• Manage implementation, support and maintenance of company-wide Quality Objectives, including analysis and trending of key quality system elements on a periodic basis
• Manage the CAPA program; review root cause analysis and proposed corrective actions; track the implementation and effectiveness of committed corrective and preventive actions
• Manage the supplier/vendor qualification program and Approved Supplier/Vendor List, including Quality Agreements with contractors, suppliers and vendors

 EXPERIENCE REQUIREMENTS:  

• 2 years of in-depth Quality System implementation in compliance with FDB, FDA, and ISO 13485
• 2 years of multiple simultaneous project QA or client facing QA consultancy
• Experience should include Design Controls, SDLC, Risk Management, and Verification/Validation Plans
• Knowledge of statistics and application of statistical methods
• Experience in a medical device company is desirable; understanding of US FDA Quality System Requirements, ISO/EN 13485 and CE Mark requirements is desirable

EDUCATION REQUIREMENTS:  

• Bachelor's Degree in an engineering/ scientific discipline
• CQE, RAC, RAB or other quality and regulatory certificates are beneficial