Quality Assurance Specialist

2 months ago


Shakopee, Minnesota, United States The IMAGINE Group Full time
Quality Assurance Engineer Job Description

At The IMAGINE Group, we strive to deliver exceptional quality solutions to our clients. As a Quality Assurance Engineer, you will play a crucial role in driving preventative quality measures that support the needs of our medical device customers.

Key Responsibilities:
  • Collaborate with internal functions to own corrective actions, including training, process improvements, SOP updates, quality audits, and validation efforts.
  • Prepare and present reports and compliance documentation to medical customers as necessary.
  • Maintain and review documentation for regulatory submissions and inspections related to product quality.
  • Ensure products meet all regulatory requirements, including FDA, ISO, and other relevant quality standards.
  • Assist in maintaining and developing our Quality Management System (QMS) to the requirements of ISO 9001:2015, Quality Manual, and current company objectives.
Requirements:
  • Experience in supplier and/or customer quality in a manufacturing environment.
  • Working knowledge of utilizing statistical analysis tools such as, control charts, ANOVA charts, sample size determination, etc.
  • Robust analytical and problem-solving skills, with the ability to interpret complex data and provide actionable insights.
  • Able to read and interpret written specifications and maintain documentation required internally and by the customer.
  • Microsoft Office suite of products experience is required.
  • Working knowledge of Six Sigma methodologies.
Preferred Qualifications:
  • Must be self-motivated and the ability to prioritize tasks.
  • Must work well in a team and the ability to perform with little supervision.
  • Must follow and support all quality, management and corporate policies and instructions.

The IMAGINE Group is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to building a diverse and inclusive workforce.



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