Quality Analyst

At STERIS, the Quality Analyst is responsible for assisting in administration of the quality management system at our Minneapolis site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. The Analyst also supports production and quality operations by coordinating and performing problem-solving investigations, pre-reviews and final acceptance/run release of processing runs that contain non-conformances. You will be responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, dosimetry results, generation of test methods, audits, scheduling, validations, record keeping and reporting.

• Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support, mentoring and oversight.
• Responsible for oversight of all products and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians.
• Responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and the associated non-conformance investigations.
• Initiate and/or participate in corrective actions, problem-solving and continuous improvement activities.
• Review collected data to perform statistical analysis and recommend process changes to improve quality.
• Monitor and report on performance metrics.
• Collaborate with other departments and facilities within the company on quality related issues.
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.
• Perform other duties as assigned.
  
  

Required:

• Bachelor's degree in scientific or technical field.
• Minimum one to five years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum one to five years of experience working in an ISO certified environment required.
• Proficiency with MS Office including Word, PowerPoint, Excel and SharePoint.

Preferred:

• Minimum one to five years of experience in microbiology, medical device or other regulated industry preferred.
• Working knowledge of FDA QSR/ISO 17025 regulationspreferred.
• Knowledge of QMS program Track Wise similar system.
  
  

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.

Here is a brief overview of what we offer:

* Market Competitive Pay

* Extensive Paid Time Off and (9) added Holidays

* Excellent Healthcare, Dental and Vision Benefits

* Long/Short Term Disability Coverage

* 401(k) with a company match

* Maternity and Paternity Leave

* Additional add-on benefits/discounts for programs such as Pet Insurance

* Tuition Reimbursement and continued education programs

* Excellent opportunities for advancement in a stable long-term career

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