Quality Assurance Specialist - Pomona, United States - Millennium Biomedical, Inc

Description

About us
Millennium Biomedical, Inc is a small business in Pomona, CA. We are professional, agile, professional and our goal is to To provide a way to measure success.


Our work environment includes:

• Modern office setting
• Food provided
• Modern office setting
• Safe work environment

The QA Specialist manages directly, or through delegation, the following duties and


responsibilities:

• Ensures the requirements of EN ISO 13485:2016+A11:2021, QSR 21 CFR 820, MDD93/42/EEC under Annex II and MDR 2017/745 under Annex IX are understood,implemented, and maintained throughout the organization and that the integrity of the QMS is maintained when related changes are implemented
• Ensures corrective and preventative actions are implemented to resolve issues identified in internal and/or external audits.
• Oversees and initiates system audits per EN ISO 13485:2016, QSR 21 CFR 820, MDD93/42/EEC under Annex II and MBI's Quality Management System defined in the quality manual and related standard operating procedures and work instructions.
• Reports to top management on the performance and effectiveness of the QMS including a review of pertinent product, process, and customer data via management review, including any recommendations for improvement.
• Ensures the promotion of awareness of applicable regulatory requirements and quality management requirements throughout the organization so that they are known and understood at points of need and ensuring that responsibilities and authorities are defined, documented, and communicated within the organization.
• Establishes the interrelation of all personnel who manage, perform, and verify work affecting quality and ensuring their independence and authority necessary to perform these tasks. Responsibility and authority for these critical activities are specifically defined in applicable quality system procedures and are generally defined as specified in personnel job description and organization charts.
• Communicates and works with external parties in matters relating to the QMS
• Works with Contract Suppliers to establish and maintain effective calibration program, pest control and other services acquired by MBI.
• Managed audit program and coordinated internal audits.

Pay:
$75, $80,000.00 per year


Benefits:

• Dental insurance
• Health insurance
• Paid time off

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• Inperson
• Office

Experience:

• Manufacturing: 2 years (required)

Ability to Commute:

• Pomona, CA required)

Work Location:
In person