Quality Engineer II

The Quality Engineer II our Maplewood / St. Louis MO 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. This role 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 position requires working onsite in our Maplewood Missouri location.

Day Shift: Monday to Thursday (four 10-hour day schedule) most Fridays off!

• 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.
• Perform other duties as assigned.

Required:

• Bachelors degree in Engineering
• Minimum 3 years combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum 3 years experience working in an ISO certified environment required.

Preferred:

• Experience with medical device or other regulated industries preferred.
• ASQ- Certified Quality Auditor and/or Quality Engineer QMSR or familiarity with QMSR/GMP regulations preferred.

Other:

• Excellent problem-solving skills
• Has a continuous improvement mindset embracing new ideas and ways to think about a project.
• Maintains strong relationships cross functionally to solve problems collaboratively.
• Communicates through facts and data.
• Demonstrates the technical aspects of the role.
• Applies new technical tools and concepts under the direction of others.
• Invests in growth through formal training or stretch project.
• Completes assigned tasks on time by following standard work processes.
• Thrives on change and adapts to leader-initiated changes.
• Participates in change initiatives to better understand business and project goals.

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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