|Title:||Quality & Compliance Specialist|
|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.
Assists in administrating Quality Assurance, Quality Control, and Compliance & Regulatory Affairs activities on behalf of the company’s efforts regarding design, development, and manufacturing of dental hand instruments.
- Help develop, document, and maintain process documentation and controls relevant to standardization of operations and product quality.
- Participates in the Material Review Board for dispositioning of product which is determined to be defective or out of tolerance per the appropriate specification.
- Assist with Root Cause Analysis of process and product issues to determine need for Remedial, Corrective, or Preventive Action.
- Conduct Internal Quality Audits.
- Participate in Management Review.
- Coordinates Product and Process validation and testing.
- Aid in the requisition, acquisition, 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 requirements.
- Be aware of relevant industry standards and knowledgeable in their application as they pertain to the company’s products.
- Assist in responding to Customer Complaints, Adverse Events, and associated Medical Device Reports (incl. relevant supporting documents).
- Work with Production personnel to develop SOPs and reference documentation.
- Assist with Process Improvements including Lean Manufacturing development and implementation.
- Develop, distribute, and maintain documents within the QMS.
- Assists in Inspection (Incoming, Final, and WIP) as needed to determine and identify the state or condition of the product.
- Help maintain accurate Inspection records for reporting and trend analysis.
- Aid in the development of reports for analyzing and understanding Quality performance via defined KPIs.
Compliance and Regulatory Affairs:
- Keep abreast of the changes to and introduction of new compliance and regulatory matters which impact or have the potential to impact the company’s activities. Analyze and report on effective ways to respond.
- Aid in the activities relevant to the preparation and submission of 510(k) and CE Marking documentation for regulatory product acceptance/approval (technical files, clinical evaluations, etc.).
- Coordinate document preparation and generation for Dealer Partner’s product registration requirements.
- Help coordinate and conduct Technical File reviews, Risk Assessments (incl. FMEA’s), and maintain Device Master Records.
- Coordinate Customer and Registrar Quality Audits and assist with Regulatory Inspections.
- Maintain regulatory product listings and supporting documentation (incl. company’s Certificate to Foreign Government, UDI listings, etc.).
- Maintain FDA registration for facility (incl. accurate contact information).
Associate’s Degree or equivalent college or university program certificate; and two to four years related experience and/or training. Ability to read, analyze, and interpret common scientific and technical journals. Ability to define problems, collect data, establish facts, and draw valid conclusions.
American Eagle Instruments, LLC /Young Innovations, Inc. is an Equal Opportunity Employer & E-Verify participating employer.