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Job Openings >> Quality Manager
Quality Manager
Summary
Title:Quality Manager
ID:1688
Department:Quality
Location:Colorado Springs, CO
Description

Biomedical Innovations, a Nissha Company, is seeking a Quality Manager who will be responsible for planning, organizing, directing, and controlling all activities related to the implementation and execution of the Quality Management System (QMS).

Essential Functions and Basic Duties:

  • Follows all employee guidelines and Quality Systems Regulations (QSR's) as defined by BMED's proctices, policies and Standard Operating Procedures (SOP's) to ensure that customer requirements and FDA (or equivalent) regulations are met.
  • Demonstrates knowledge and acts in accordance with BMED's Employee Guidelines and applicable quality standards as outlined in BMED's Quality Manual.
  • Abides by all safety and security rules set forth by the company and regulatory agencies.
  • Regular attendance is required.
  • Performs other duties as assigned.

Minimum Qualifications:

Qualifications & Experience: 

  • Three years’ experience required working in an ISO 13485 and FDA- regulated medical device environment.
  • Experience in process improvement methods desired.
  • Experience reading and understanding regulations, standards, drawings and procedures.
  • Supervisor experience strongly preferred.
Education:
  • Bachelor's degree in Business, Science or Engineering required. Master's degree preferred.
  • CQE or CQM Certification desired.
Knowledge, Skills and Abilities:
  • Knowledge of FDA cGMP and validation requirements and practices required.
  • Working knowledge of the operation of related instrumentation.
  • Proficient computer skills with documentation related databases and Microsoft Office (Word and Excel),

Great benefits offered including medical, dental, 401K, education assistance, and more!


Biomedical Innovations, a Nissha company, 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.

If you need assistance with completing the online application process, please call Biomedical Innovations at (719) 591-5300.

 

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