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Quality Assurance Specialist

2 months ago

Maplewood, Minnesota, United States 3M Healthcare US Opco LLC Full time
Thank you for considering a career with our organization. Recruiting the right talent is essential to our objectives.

We are in the process of transitioning to a new identity while maintaining our commitment to excellence in healthcare solutions.


Job Overview:
As a Quality Assurance Specialist, you will play a pivotal role in ensuring the highest standards of quality for our products.

At our company, we strive to enhance healthcare outcomes through innovative solutions.

Your contributions will directly impact the quality of our offerings and the satisfaction of our customers.


Key Responsibilities:

In this role, you will:

  • Provide Quality Assurance (QA) support for marketed products, collaborating extensively with cross-functional teams including laboratory, manufacturing, regulatory, and clinical departments.
  • Engage in product change management, conduct internal and external audits, and participate in cost reduction initiatives.
  • Lead investigations into customer complaints, manage risk assessments, and validate testing methods.
  • Oversee shelf-life stability studies to substantiate product claims.
  • Act as the Quality representative for Pilot Plant operations, ensuring compliance with Quality Management System (QMS) standards.
  • Ensure adherence to internal Standard Operating Procedures (SOPs) and external regulatory requirements.
  • Coordinate processes for non-conforming products and lead Corrective and Preventive Action (CAPA) initiatives.

Qualifications:

To excel in this position, you should possess:

  • A Bachelor's Degree or higher in a relevant field, coupled with a minimum of two years of experience in product quality, engineering, or laboratory settings.
  • Additional qualifications that would enhance your candidacy include:
    • A degree in Mechanical Engineering, Chemical Engineering, Statistics, Chemistry, or Microbiology.
    • At least four years of experience in a regulated environment.
    • Demonstrated leadership skills with a focus on continuous improvement.
    • Experience in leading QA efforts for marketed products.
    • Proficiency in statistical analysis and quality control methodologies.

Work Environment:

This position offers a hybrid work arrangement, allowing for flexibility in your work location.


Compensation and Benefits:

We offer competitive compensation and a comprehensive benefits package designed to support your well-being.

We are an equal opportunity employer, committed to diversity and inclusion in the workplace.