Job Title:  Senior Quality Engineer- Conroe, TX

The Role

As a Senior Quality Engineer at STERIS you will provide work direction for up to five Lab Technicians, manage test equipment programming, and provide support and mentorship for two Quality Engineers. This role reports to the Senior Quality Manager and leads projects to maintain and improve the quality system in accordance with applicable standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, and EU MDR. The Senior Quality Engineer leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.   

Our Conroe, Texas facility (near Houston) offers a dynamic, fast paced work environment with a family-oriented, supportive, team-based culture.  Advance and grow in your career as a valued member of a high performing team at STERIS!  

Travel:  Domestic Travel up to 10 – 20% to customer or supplier sites as needed, or for FAT (First Article Testing) on new equipment.

What STERIS Will Offer You

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.

• Competitive pay
• Annual merit bonus and incentive plans
• Medical, vision, prescription, dental and life insurance
• 401(k) with a company match
• Paid vacation time and paid holidays
• Onsite parking
• Tuition assistance
• Opportunities for advancement

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What You Will Do

• Create and update post market surveillance reports and conduct FMEA risk analysis.
• Serves as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer. 
• Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements. 
• Lead process and product corrective actions and problem-solving activities. 
• Perform statistical analysis and recommend process / product changes to improve product and service quality. 
• Lead supplier audits and corrective actions; leads and supports internal and external quality system audits.
• 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. 
• Supervise Quality Engineers and/or other Quality staff in the execution of their assigned duties and objectives.
• Maintain product integrity and quality through the evaluation and disposition of nonconforming materials and processes. 

What You Need to Be Successful

• Bachelor’s Degree Engineering or related technical field
• 5+ years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• 3 + years of experience with medical device or other regulated industries preferred.
• 5 + years of experience working in an ISO certified environment required; ASQ, QSR or familiarity with QSR/GMP regulations preferred.
• Excellent critical thinking skills with focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and acting on own initiative.
• Proactive approach to problem solving and following up on tasks.
• Ability to prioritize effectively to manage multiple projects, strong time management skills
• 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.
• Experience with statistical analysis software and Visio preferred.
• Ability to lead and develop direct reports.
• Ability  to travel domestically up  to  10- 20 % to customer or supplier sites as needed.