Innovation

Our Leadership Team continues to invest in our associates - Our forward looking culture is like no other.

Health & Wellness

With a focus on healthy mind and body,  we strive to expand health and wellness incentives across our global operations.

Global Force

We bring together leading cultures and innovators - Join our dynamic and a culturally rich work environment.

Changing the World

Biomedical Innovations products change the pace of patient care with innovative wireless monitoring.


Openings >> Quality Manager
Quality Manager
Summary
Title:Quality Manager
ID:1145
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 Responsibilities Include:

  • Responsible for implementation and management of the Quality Control Section.

  • Responsible for the establishment and tracking of Quality KPIs.

  • Develop short and long-range Quality Department plans and budgets.

  • Develop and implement standards, methods, and procedures for process validations, equipment calibration and contamination control.

  • Implement and ensure execution of all inspection activities.

  • Assure that all work performed conforms to 21 CFR 820 and ISO 13485 standards and is conducted in accordance with cGMP regulations on the production floor.

  • Write, revise and review Standard Operating Procedures (SOPs), validation protocols and test plans and protocols that are pertinent to company product quality.

  • Implement performance standards for testing of equipment and scheduling of calibrations.

  • Oversee the resolution of customers’ technical issues and complaints.

  • Schedule and conduct corporate Management Reviews.

  • Identify and implement process improvements.

  • Address and implement corrective and preventive actions

  • Manage the scheduling and execution of internal and external audits.

  • Act as the primary company interface with the FDA and ISO 13485 Registrar.

  • Act as the Regulatory Affairs Officer for the company

  • Responsible for selection, supervision, and performance management of department employees.
  • Participate in staff management training and effectively manage employees in compliance with federal and state employment laws and regulations.
  • Interview, hire, and train new department employees.
  • Conduct timely performance reviews, establish clear goals, and support learning opportunities for job skills and career growth.

Minimum Qualifications:

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

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 (716)847-7592.

 

Alternatively, you can apply to this job using your profile on one of the following sites:

Powered by ApplicantStack

Advancement Opportunities

We believe in promoting and growing talent from within! Employees are offered opportunities to apply for open positions.

Compensation and Benefits

Specific benefits will vary by location. In general they include:

  • Competitive Financial Compensation
  • Training and Development
  • Healthcare Coverage
  • Health and Wellness Incentives
  • Disability Protection
  • Tuition Reimbursement
  • Retirement Plans
  • Service Awards

Diversity EEO Statement

Graphic Controls is an Equal Opportunity Employer. Graphic Controls considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or an other legally protected status.

Culture

For over 60 years, Graphic Controls has been a Company that values it's employees and their hard work. Employees are offered great benefits and opportunities which make coming to work everyday something to look forward to. Employee satisfaction is proven by the simple fact that our average length of service is over 15 years.