Senior Quality Engineer

Date: 7 Oct 2024

Location: manchester, MAN, GB, M23 9GF

Company: Steris Corporation

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.

HOW YOU WILL MAKE A DIFFERENCE

About you:

Do you want to spend your working time making a difference in the world around you? Are you passionate about helping our incredible national health service make a difference? Do you care about keeping vulnerable patients safe? If so, then a career with Steris IP could be a great fit for you.

About Us:

At Steris IP we are the trusted experts in surgical instrument sterilisation. We offer on and offsite re-processing, alongside reliable instrument maintenance solutions. Our diverse and talented teams use cutting edge technology to ensure that the highest quality of infection prevention is delivered to our customers.

We are currently recruiting for a Senior Quality Engineer vacancy. This is an excellent opportunity to join the business at professional level to support our IP Sites

The Senior Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards.  This role leads complaint/CAPA investigations, 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.

What's involved

  • Serves as the Core Team Member on cross-functional service development teams with focus on the execution of quality plans and design/service transfer. 
  • Develops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements. 
  • Leads process and product corrective actions and problem-solving activities. 
  • Reviews the current quality system and recommend / implement improvements as needed. 
  • Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.
  • Leads projects focused on quality system, product quality and service quality improvements. 
  • Develops analyses and reports on the performance of the quality system. 
  • Leads supplier audits and corrective actions. 
  • Leads and supports internal and external quality system audits.
  • Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. 
  • Collaborates with other departments and facilities within the company on quality related issues. 
  • Supervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
  • Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes. 
  • Perform all other duties as assigned. 

Experience and Skills required

  • 5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
  • 5 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 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.
  • Experience with statistical analysis software and Visio preferred.

 

 

Equal Opportunities

STERIS plc provides employment and advancement opportunities without regard to age, disability, gender reassignment, marriage or civil partnership, pregnancy and maternity, race, religion/belief, sex (gender), sexual orientation or any other legally protected characteristic as defined by employment law. The Company bases all employment decisions on merit, qualifications, skills, and abilities with the intention that the best candidate is selected for each position.

 

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.  WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.