Senior Quality Engineer (Medical Devices)

Cannon Quality Group is searching for a dynamic, experiencedSr. Quality Engineerto join our growing team.

PURPOSE OF JOB:3rd-level engineering role at CQG. Primarily responsible for the requirements definition, design, customization, configuration and delivery of highly effective quality management system solutions that are relevant to the client’s business stage.

Responsible for leading, organizing and managing the QA activities on the core solutions themselves but also on specific client implementations; essentially charged with client facing engineering solution development and implementation.

Additionally, this role may be tasked with mentoring junior staff as part of a broader leadership development program. This will involve day-to-day management of activities and coaching of other engineers and document control staff.

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
• Develop strategy with Operations to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation and training
• Audit DHF
• Lead, manage, and approve DMR, DHR, and Validation Protocols and Reports related to processes, equipment, facility and computer systems
• Partner with R&D on technical File for CE Marking
• Create and review design input/output/verification/validation documents as appropriate
• Manage the equipment calibration program
• Partner with R&D on EMC and safety (UL/CSA) certification
• Create and review documents for 510(k)s
• Lead and Manage activities for receiving inspection, device history records, component release and process validation

Quality Systems (50%):

• 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
• Establish and lead 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 the supplier/vendor qualification program and Approved Supplier/Vendor List, including Quality Agreements with contractors, suppliers and vendors

EXPERIENCE REQUIREMENTS:

• Experience should include Production and Process Controls, Process Validations, Computer System Validations, DIR Specification Development, and Test Method Development/TMV Execution
• Experience in a medical device company is desirable. Understanding of US FDA Quality System Requirements, ISO/EN 13485:2003, and CE Mark requirements is desirable
• 5+ years of in-depth Quality System Implementation in compliance with FDB, FDA, and ISO 13485
• Knowledge of statistics and application of statistical methods
• 5+ years of multiple simultaneous project QA or client facing QA consultancy

EDUCATION REQUIREMENTS:

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

JOB REQUIREMENTS:

• Positive, results-oriented and energetic team player
• Ability to prioritize and manage to critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently
• Experience using Microsoft Access, Word, Excel, PowerPoint, Microsoft Outlook, and SolidWorks
• Ability to deal with unresolved situations, frequent changes, delays or unexpected events
• Ability to follow established policies and procedures and comply with regulatory requirements