|Job Location:||Missoula, MT|
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, competitive salaries and benefits and a dynamic work environment. AEI is comprised of a diverse and intelligent workforce. Our employment practices are implemented without regard to race, color, religion, national origin, sex religious beliefs, age, disability, sexual orientation or any other basis protected by federal, state or local fair employment law practices.
- Help develop, document, and maintain process documentation and controls relevant to standardization of operations and product quality.
- Conducts Product testing and validation.
- Aids in the administration of the requisition, receipt, commissioning, validation, and maintenance of testing equipment.
- Represent the Quality department in any company projects which impact product quality to ensure compliance and fulfillment of regulatory demands.
- Assist in responding to Customer Complaints or Concerns including completion and submission of MedWatch and other applicable regulatory reports
- Coordinate Return Authorizations and crediting customers with Customer Service personnel.
- Work with Production personnel to develop SOPs
- Assist in Lean Manufacturing development
- Develop and distribute documents within the QMS
Support Supplier Management and Incoming Inspection process, including;
- Coordinate supplier approval requests,
- Montitor/maintain supplier files (e.g., certifications, nonconformance reports),
- 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 records (e.g., product certification).
Support production processes and controls, including;
- Work with the Process Specialist and R&D personnel to establish inspection plans,
- Coordinate and assist with audits of production processes,
- Complete and maintain all applicable records (e.g., Device History Records),
- Assist with Calibration (Gage R&R) and Maintain records,
- Review and maintain preventive maintenance records, and
Support nonconforming material investigations, including…
- Initiating MRB records when made aware of nonconforming product,
- Verifying acceptance status of material return due to customer complaints,
- Analyzes quality data and issue reports accordingly.
Support other cross-departmental and operations initiatives, including;
- 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.
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