Quality Engineer

Applied Medical Technology•Brecksville, OH

19d•Onsite

About The Position

Develop, implement, maintain and support activities for quality improvement and manufacturing programs. Support the CAPA program and address customer complaints.

Requirements

Four Year degree, preferably in a technical discipline
3-5 years related experience in a regulated environment, preferably medical device
Proficiency with MS Office
Familiarity with use of mechanical and electrical test equipment
Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing
Ability to analyze and aggregate data using statistics
Ability to effectively communicate with others
Ability to complete and understand complex analysis of numbers
Ability to read, analyze and interpret written materials
Ability to meet and exceed company standards
Ability to ensure compliance with company policies
Ability to respond appropriately to feedback to make improvements
Ability to maintain positive working relationships
Ability to troubleshoot and solve problems
Must be able to hear and verbally communicate for hours at a time
Must be able to use computer equipment, electrical and general hand tools
Knowledge of modern business communication, office procedures and methods
Skill to use a personal computer and various software packages such as Microsoft Office Suite
Ability to establish priorities
Ability to work independently with minimal supervision
Ability to facilitate teamwork
Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume
Ability to apply concepts of basic algebra and geometry
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

Nice To Haves

Experience preferred with ISO 13485, ISO 14971 and FDA QSR for Medical Devices

Responsibilities

Product testing and evaluation
Maintain employee training
Annual sterilization testing
Lead product quality investigations to a successful conclusion
Execute risk assessments, collect supporting information and provide recommendations for management consideration
Interface with other departments to provide guidance on CAPA completion
Provide technical guidance to QA and QC personnel
Represent quality interests and concerns on project teams
Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements
Investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection
Collect, analyze, trend and communicate quality data throughout the organization
Identify and help facilitate continuous improvement, corrective and preventive
Resource in Engineering Change Order review process
Mentoring, education and training of QA personnel
Assume additional responsibilities as necessary at the discretion of QA
Develop programs and methodologies for analyzing and presenting quality system data
Identify program opportunities for improvement and drive procedure updates when required
Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements