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Quality Assurance Specialist

1 month ago

Glencoe, Minnesota, United States BD (Becton, Dickinson and Company) Full time
Job Description

The Quality Engineer II is responsible for ensuring compliance with Quality Systems and regulatory requirements. This role involves the application and interpretation of plant/department procedures to maintain consistency and compliance.

The Quality Engineer II uses the Company Quality Systems to ensure overall compliance and has the knowledge necessary to apply the appropriate statistical and analytical tools.

Key responsibilities include:

  • Maintaining International Organization for Standardization (ISO) and regional regulatory requirements
  • Developing Device History Files and maintaining them in a manner consistent with regulatory requirements
  • Generating process/product quality information in the form of CTQ (Critical to Quality) indices, recommendations, and solutions to emerging issues
  • Supporting the coordinated integration of new products into Manufacturing/Operations
  • Ensuring BD Diagnostic Systems divisional, departmental policies, procedures, practices, and facilities are in compliance with all applicable regulatory policies

The ideal candidate will have a strong understanding of Quality Systems and regulations, as well as excellent communication and problem-solving skills.

Requirements:

  • BS in a related field with 2 years of quality and/or manufacturing experience
  • Or MS with 1 year of quality and/or manufacturing experience and project management experience
  • Knowledge of GLP/GMP/ISO requirements and sound understanding of the pertinent Quality System/Regulations
  • Computer skills in word processing, spreadsheets, and a statistical package
  • Excellent communication skills

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.

It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

We welcome people with the imagination and drive to help us reinvent the future of health.