Senior Quality Engineer

This position will be onsite in our Mason, OH Headquarters. Must be able to relocate or commute to this location.

POSITION SUMMARY:

This position will work closely with AtriCure engineering, manufacturing and suppliers to ensure that quality system activities are completed. The Senior Quality Engineer is responsible for the development and implementation of company-wide quality systems including:

• Compliance with global regulatory requirements
• Development to support new product development activities
• Ensuring that the quality management system focuses on continuous improvement

ESSENTIAL FUNCTIONS OF THE POSITION:

• Develop and implement quality systems and establish procedures in compliance to global regulatory requirements (e.g. FDA, EU MDD, CMDR, ISO, etc.)
• Direct and support Suppliers, Engineering, Inspection, Calibration, Internal Auditing, CAPA, Quality Engineering and Document Control
• Represents Quality for projects including new products and existing product improvement.  Supports protocol, procedure, design controls and specification development
• Work closely with Quality Management and other departments in developing and executing company strategies
• Work closely with the quality management and other departments in developing documentation to support technical design reviews.
• Negotiation and problem-solving skills
• Assist with FDA and ISO audits. 
• Perform internal and supplier audits as necessary
• Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts
• Generally, operates with appreciable latitude for actions and/or decisions on day-to-day activities with minimal guidance from management.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree in engineering required or demonstrated equivalent combination of education, training and experience.
• Five years Engineering experience
• FDA and ISO 13485 knowledge
• Problem Solving/Troubleshooting experience
• Auditing experience (Financial/Quality)
• Experience with reading technical specifications
• Inspection/testing experience
• Data analysis experience
• Computer/data entry skills
• Written/report writing skills
• Verbal communication skills
• Experience with reading blueprints, drawings, and specifications
• Regulatory experience
• Requires advanced technical abilities as well as an understanding of product design, manufacturing and quality systems
• Supervision experience
• Strong technical foundation and must be able to lead and coordinate activities to meet the project / product release schedules 
• Proven creativity and experience in planning, developing, and executing QA initiatives to ensure regulatory compliance
• Statistical use experience
• Engineering/design background
• Ability to travel 15%

PREFERRED QUALIFICATIONS:

• FDA and ISO audit experience
• MDD, CMDR and JPAL knowledge
• ASQ Certified Quality Engineer
• ASQ Certified Quality Auditor
• Strong metrology background

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to pass pre-employment drug screen and background check

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