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Job Openings >> Quality Engineer
Quality Engineer
Summary
Title:Quality Engineer
ID:1571
Department:Quality
Location:Colorado Springs, CO
Description

Position Summary:

This position is responsible for leading activities concerned with the application and maintenance of the Quality System for products and services offered by performing the essential functions and basic duties outlined in this job description. Other responsibilities include interfacing with customers on quality related aspects of projects.

Essential Functions and Basic Duties:

  • Follow all employee guidelines and Quality Systems Regulations (QSR's) as defined by BMED's practices, policies and Standard Operating Procedures (SOP's) to insure that customer requirements and FDA (or equivalent) regulations are met.
  • Investigate and analyze manufacturing, customer and supplier problems.
  • Support the establishment of quality standards for products, processes and procedures.
  • Perform capability studies, GR&Rs, and first articles on products and development Control Plans.
  • Participate in FMEA, DFM and Validation Activities
  • Implement process improvements including fixtures, tools, production checks, testing and inspection of devices.
  • Assist in troubleshooting line manufacturing, supervision and engineering activities.
  • Review documentation and standards pertinent to production and development.
  • Help determine and implement the test facilities and inspection required for quality assurance activities.
  • Establish systems of measurement to improve the efficiency and adaptability of the business and production processes.
  • Prepare quarterly annual business reports for the customer and company, as required.
  • Review and/or audit manufacturing process audits.
  • Backup to other department functions as needed

Qualifications

Education / Certifications:

  • Bachelor’s Degree (BA) from a four-year College or University

Required Knowledge/Experience:

  • Minimum of 3 years of related experience (Medical Device preferred)
  • Familiarity with Quality Systems and regulatory agencies. Preferably ISO 13485 and FDA 21 CFR 820
  • Certification through ASQ as a CQE, CSSGB or CSSBB preferred

Skills/Abilities:

  • Highly organized, detail oriented and works effectively as both a team member and independent contributor
  • Demonstrated proficiency in MS Suite, particularly MS Word and Excel
  • Knowledge of Minitab preferred
  • Ability to work independently, at time with minimal supervision
  • Acts with sound and proactive decision making, seeks clarification as appropriate to minimize/eliminate delays
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals
  • Ability to write routine reports and correspondence
  • Ability to apply logical and systematic understanding to carry out instructions furnished in written, oral or diagram form.
  • Ability to deal with problems involving several concrete variables in standard situations
Great benefits offered including medical, dental, 401K and more!

Biomedical Innovations is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Biomedical Innovations will provide reasonable accommodations for qualified individuals with disabilities.

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