Quality Engineer

Position Summary

The Quality Analyst is responsible for assisting in administration of the quality management system at a 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 leads complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles.  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. 

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. 

Duties

1. Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support, mentoring and oversight. 
2. Responsible for oversight of all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians.
3. Responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading the associated non-conformance investigations.
4. Initiate and/or participate in corrective actions, problem-solving and continuous improvement activities. 
5. Perform internal audits at other AST facilities, including identification of non-compliances and report generation.  Responsible for managing remediation of internal audit observations assigned by site Quality Manager.
6. Manage creation of new quality system policies and procedures and revisions to existing policies/procedures. 

Duties - cont'd

1. Review collected data to perform statistical analysis and recommend process changes to improve quality.
2. Monitor and report on performance metrics. 
3. Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. 
4. Collaborate with other departments and facilities within the company on quality related issues. 
5. Lead quality system programs (i.e. calibration, maintenance, training, CAPA, complaints, non-conformances, supplier quality, management review, operational qualifications, document control, change control, risk management, etc).
6. Overall responsibilities include commitment to ensure external and internal requirements ar met according to documented policies, procedures, standards and regulations.
7. Perform other duties as assigned. 

Education Degree

Required Experience

1. 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience or minimum of 6 months on-site STERIS internship or co-op experience.
2. 1-5 years of experience with medical device or other regulated industries preferred.
3. 1-5 years of experience working in an ISO certified environment required.
4. Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
5. Excellent problem-solving skills
6. Focus on identification of potential issues and continuous improvement.
7. Experience working on cross-functional teams and on own initiative.
8. Demonstrated excellent organizational, oral and written communications skills.
9. Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
10. Ability to work in a fast-paced, regulated environment with strict deadlines.
11. Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra.