Quality Engineer

STERIS Canada Corporation; Leicester; On-site; GBP 30,000 - 45,000; Full time

Job summary

A global healthcare solutions provider is seeking a Quality Engineer to maintain and improve quality systems following regulatory standards. The role involves participating in product development, conducting audits, and leading quality improvement initiatives. Ideal candidates have experience in manufacturing or quality engineering and strong problem-solving skills. This position is located in Leicester, UK, and offers opportunities for advancement.

Qualifications

• 1-5 years of combined Manufacturing/Quality Engineering/Quality Systems experience.
• Experience with medical device or other regulated industries preferred.
• Experience working in an ISO certified environment required.
• Familiarity with QSR/GMP regulations preferred.
• Must have PC experience.

Responsibilities

• Participate on cross-functional new product development teams.
• Support complaint/CAPA investigations.
• Develop and implement statistically valid sampling plans.
• Initiate and/or participate in problem-solving activities.
• Perform quality system audits.

Skills

Problem-solving skills

Statistical analysis

Organizational skills

Communication skills

Tools

Excel

Statistical analysis software

Visio

Job description

Select how often (in days) to receive an alert:

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 supporting the medical and pharmaceutical industries? Do you care about keeping patients and people safe? If so, then a career with Steris could be a great fit for you.

About Us:

At Steris we arethe technological leader indesign, production, and supply of sterilization test equipment and monitoring systems.

We are currently recruiting for a Quality Engineer vacancy. This is an excellent opportunity to join the business at a skilled professional level and help us maintain and build on the excellent quality standards we commit to.

The Quality Engineer will be 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

What is involved

• Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
• 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
• 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 Experience

• 1-5 years of combined Manufacturing/Quality Engineering/Quality Systems experience or minimum of 6 months on-site STERIS internship or co-op experience.
• 1-5 years of experience with medical device or other regulated industries preferred.
• 1-5 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.

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 UK 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 18,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.