Quality & Compliance Technician

Company Overview
At American Eagle Instruments/Young Innovations, we pride ourselves on hiring and developing the best people. The growth of AEI has been fueled by the commitment and hard work of this special group of people. As an established industry leader, AEI offers excellent career growth opportunities, a very attractive starting wage, annual bonus eligibility and a complete benefits package that includes medical, dental, vision, 401k with match, life and disability insurance. AEI offers a dynamic work environment, positive culture and is comprised of a diverse and intelligent workforce.

Together with our parent company, Young Innovations, we manufacture and market high quality dental instruments, equipment and supplies with sales in excess of $140 million. With an outstanding reputation for quality, our company has a broad portfolio of market leading products across a variety of categories.
 

Responsibilities

Quality Assurance activities including:

• Coordinate the administration of Customer Complaints and/or Concerns including completion and submission of FDA MedWatch and other applicable regulatory reports,
• Coordinate Return Authorizations and any subsequent reporting with corporate Customer Service personnel,
• Assist in Lean Manufacturing development, 5S, and product and process improvement in general,
• Develop, modify, and distribute documents within the QMS,
• Help develop, document, and maintain process documentation and controls relevant to standardization of operations and product quality,
• Conducts Product testing, incl. verification and validation,
• Assists in the specification, requisition, receipt, commissioning, validation, and maintenance of equipment, and
• Represent the Quality department in any company projects which impact product quality to ensure compliance and fulfillment of regulatory demands.

Support Supplier Management and Incoming Inspection process, including:

• • Coordinate supplier approval requests,
  • Monitor/maintain supplier files (e.g., certifications, nonconformance reports, CAPAs, KPI reporting, etc.),
  • Inspect/measure parts against inspection plans, product specifications, and defined purchase criteria,
  • Make recommendations to improve efficiencies and inspection accuracy, and
  • Complete and maintain all applicable Quality records (e.g., product certification).

Support production processes and controls, including:

• • Work with Operations and Process Engineering personnel to establish appropriate inspection plans,
  • Coordinate and assist with audits of production processes,
  • Complete and maintain all applicable Quality records (e.g., Device Master Record and Device History Records),
  • Assist with Calibration, incl. scheduling and maintaining Quality records, and
  • Review and help maintain preventive maintenance records.

Additional duties 

• • Initiating MRB records when made aware of nonconforming product,
  • Verifying acceptance status of return product associated with customer complaints,
  • Analyze and report on Quality data and issue reports accordingly.
  • Documentation of engineering and production changes,
  • Overseeing training and ensuring compliance to requirements,
  • Completing assigned production, assembly, or operations tasks, and
  • Others tasks as directed by manager.

Qualifications
Associate's Degree or equivalent college or university program certificate; or two to four years related experience and/or training; or an equivalent combination of training and experience.

American Eagle Instruments, LLC /Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer.