Quality Engineer

The Quality Engineer in our Conroe, Texas facility 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. As a Quality Engineer, you will support 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 Conroe, Texas facility with up to 20% travel to other STERIS sites to support internal audits.

• 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.

Required:

• Bachelor's Degree Engineering or related technical field.
• Minimum of 1 or more years of combined Manufacturing/Quality Engineering/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 acting 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.

Preferred:

• 2 or more years of experience combined Manufacturing/Quality Engineering/Quality Systems experience.
• 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 post market surveillance or the complaint process.
• Sterilization validation experience.
• QMS software (Trackwise or other QMS software system), SAP or Oracle experience.

Other:

• Must be able to travel up to 20% domestically to STERIS sites to support internal audits.

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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