Quality Engineer

Position Summary

The Quality Engineer in our Montgomery AL location is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable standards.  The Quality Engineer supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement 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. 

This role requires onsite work in our Montgomery, Alabama facility. The working hours are  7:00 am to 4:30 pm Monday - Thursday and 7:00 am to 11:00 am on Friday (“Four 9s and a 4”).    Travel up to 10% including mostly domestic travel with some opportunities for international travel. 

What You’ll do as a Quality Engineer

• Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance. 
• Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis. 
• Initiate and/or participate in process and product corrective actions and problem-solving activities. 
• Update/establish documented work instructions as needed. 
• Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
• Monitor and report on performance metrics. 
• Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. 
• Collaborate with other departments and facilities within the company on quality related issues. 
• Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials. 
• Perform quality system audits and provide guidance on corrective actions.

The Experience, Skills and Abilities Needed

Required: 

• Bachelor’s Degree in Engineering or related technical field, required.
• Minimum 1 or more years of combining Manufacturing/Quality Engineering and/or Quality Systems experience or minimum of 6 months on-site STERIS internship or co-op experience.
• Minimum of 1 or more years of experience working in an ISO certified environment required.
• Excellent problem-solving skills.
• Focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative.
• Demonstrated excellent organizational, oral, and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
• Ability to travel up to 10% including mostly domestic travel with some opportunities for international travel.

Preferred: 

• Minimum of 1 or more years of experience with medical device or other regulated industries.
• ASQ, QSR or familiarity with QSR/GMP regulations.
• Experience with statistical analysis software and Visio.
• Experience with ISO13485. 
• Strong experience with Quality Management Systems (QMS).
• Experience with Data Analytics.
• Understanding of blueprint drawings for raw materials / components.

What STERIS Offers

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

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and 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 continuing education programs
• Excellent opportunities for advancement in a stable long-term career

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