Quality Engineer - #9835334


Date: 3 days ago
City: Richmond, CA
Salary: $90,000 - $104,000 per year
Contract type: Full time
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The Quality Engineer 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

What You Will Do

  • Participate in cross-functional new product development teams with a 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 on 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 guide corrective actions.
  • Perform other duties as assigned.

What You Will Need To Be Successful

  • Bachelor Degree in Engineering or Computer Science
  • 1+ years of combined Manufacturing/Quality Engineering/Quality Systems experience or a minimum of 6 months on-site internship or co-op Quality focused experience.
  • 1+ years of experience with medical devices or other regulated industries preferred.
  • 1+ years of experience working in an ISO-certified environment is required.
  • ASQ, QSR or familiarity with QSR/GMP regulations preferred.
  • Excellent problem-solving skills
  • Focus on the identification of potential issues and continuous improvement.
  • Experience working on cross-functional teams and on my 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.
  • Experience with statistical analysis software and Visio preferred.

What We 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 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
  • Tuition assistance
  • Opportunities for advancement

Join us and help write our next chapter.

Pay range for this opportunity is [[90,000.00]] - [[104,000.00]].This position is eligible for [BONUS PARTICIPATION] OR a [INSERT COMMISSION RATE RANGE, IF APPLICABLE] commission.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

Employees (and their families) may enroll in our company-sponsored medical, dental, vision, flexible spending, health savings account, voluntary benefits, supplemental life/AD&D plans and the company’s 401k plan. Employees are covered by an employee assistance program (also available to household members) and long-term disability. Full-Time Employees are also eligible for short-term disability. Full-time Employees will also receive Paid Time Off (PTO) based on years of service and paid Holidays. Part-time employees working 20 or more hours receive a pro-ration of the full-time PTO allocation and paid Holidays based on their standard hourly work week. Full-Time employees are eligible for four weeks of paid parental leave. Part-time employees also receive paid parental leave, pro-rated based on their standard hourly work week.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

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