Quality Engineer

About the Company

Since 1985, our core business has been enteral device product development, design, manufacturing, and engineering in a state-of-the-art facility near Cleveland, Ohio. AMT’s steady growth consistently creates job opportunities in Northeast Ohio. We are always searching for new talent and would love for you to join our team! We strive to keep the small company feeling while still reaching users all over the globe.

100% on-site in Brecksville, OH.

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

• 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

None

• 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
• Experience preferred with ISO 13485, ISO 14971 and FDA QSR for Medical Devices
• Language skills:
  Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures and governmental regulations;
  Ability to write reports, business correspondence and procedure manuals;
  Ability to effectively present information and respond to questions from managers, clients, vendors and the general public
• Mathematical skills:
  Ability to calculate figures and amounts such as proportions, percentages, area, circumference and volume;
  Apply basic algebra and geometry;
  Work with probability, statistical inference, and fundamentals of geometry;
  Apply fractions, percentages, ratios and proportions to practical situations
• Reasoning ability:
  Ability to solve practical problems with limited standardization;
  Interpret various written and verbal instructions;
  Define problems, collect data, establish facts and draw valid conclusions;
  Interpret technical instructions in graphics and diagrams
• Valid driver’s license required

• Mental:
  Must effectively communicate with others; complete and understand complex analysis of numbers; read, analyze and interpret written materials; meet and exceed company standards; comply with company policies; respond appropriately to feedback; maintain positive working relationships; troubleshoot and solve problems.
• Physical:
  Must hear and verbally communicate for hours at a time; use computer equipment, electrical and general hand tools; moderate noise level; limit exposure to physical risk.

• Insurance: AMT offers major medical, dental, and vision insurance at the first of the month following 30 days of service.
• Other Benefits: AMT offers several other voluntary benefits including hospital indemnity, critical illness, term life insurance & long term disability (company paid), among others.
• 401k: AMT matches 100% of your contribution, up to 3% of your salary.
• Paid Time Off (PTO):
  In addition to nine paid holidays, AMT provides employees with paid time off (determined by length of service), starting on day one.

• Family-oriented, Positive Working Environment
• Discretionary Yearly Raises
• On-site Vending & Gym
• Annual Employee Appreciation Picnic
• Tuition Reimbursement
• Employee Referral Bonus Program
• Employee Assistance Program

AMT is an Equal Opportunity/Affirmative Action Employer.