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Job Description
Job Description
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
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