Senior Quality Engineer

STERIS; Bishop's Stortford; On-site; GBP 50,000 - 65,000; Full time

Job summary

STERIS is recruiting a Senior Quality Engineer in the UK to support new product development and maintain quality systems across manufacturing. You will work within the Medisafe team to ensure compliance with ISO13485 and regulatory requirements, leading quality activities and continuous improvement initiatives.

The role involves internal and external audits, CAPA handling, data analysis and cross-functional collaboration to uphold product safety and performance standards.

Qualifications

• Min 5 years working experience of ISO13485 or similar.
• Hands on engineering experience.
• Min 5 years working in manufacturing.
• Data analysis experience.
• LEAN knowledge.
• New product development.

Responsibilities

• Provide quality support for new product development.
• Maintain complaint and CAPA processes.
• Report responsibilities of other quality team members.
• Implement, maintain and improve Quality Management Systems and processes per organisational objectives.
• Identify opportunities for improvements and implement them in line with objectives.
• Conduct internal and external audits as required.
• Represent the quality team on projects to ensure QMS compliance.
• Support relationships with customers and regulators from a quality viewpoint; uphold the organisation's integrity.

Skills

Problem solving & root cause

People management

Communication across levels

Workload management

Education

Bachelor degree

Job description

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

Do you want to spend your working time making a difference in the world around you? Are you motivated by impactful work? Do you have a passion for Ultrasonic and sonic irrigators and consumables? If so, then a career with STERIS in our Medisafe team could be a great fit for you.

About Us

At STERIS we are a leading global provider of products and services that support patient care with an emphasis on infection prevention. Our mission is to help our customers create a healthier and safer world. Working at STERIS, you GROW, LEARN and MAKE A DIFFERENCE.

We are currently recruiting for Senior Quality Engineer vacancy. This is an excellent opportunity to join us in a division that drives the business forwards through innovation.

What's Involved

• To provide Quality support of new product development.
• To maintain complaint and CAPA processes.
• To Have Reporting Responsibilities Of Other Quality Team Members.
• To implement, maintain and improve Quality Management Systems and processes in accordance with the objectives of the Organisation.
• Investigates opportunities for improvements and implements improvements in line with the Organisation’s objectives.
• Conducts Internal Audits and External Audits as required.
• Represent the quality team on projects to ensure compliance with QMS’s.
• To support the Organisation’s relationship with Customers and regulators from a Quality viewpoint. To represent the Organisation’s image as being one of high integrity at all times when representing the Organisation both internally and externally and behave in a manner both on and off duty befitting the Organisation’s image and standards.
• To represent the Quality Manager when required and have authorities in accordance with the Authorising Signatories process as defined in the Quality Management system.
• To represent the Organisation’s image as being one of high integrity at all times when representing the Organisation both internally and externally and behave in a manner both on and off duty befitting the Organisation’s image and standards.
• Any other duties which can reasonably be expected of the post holder given their knowledge, position, skills and experience.

Required Experience

• Min 5 years working experience of ISO13485 or similar
• Hands on engineering experience
• Min 5 years working in manufacturing
• Data analysis experience
• LEAN knowledge
• New product development

Preferred Experience

• Bachelor degree
• Team leadership
• Electrical systems manufacturing

Skills

• Able to manage a busy workload.
• Good problem solving ability and root cause identification skills.
• People Management.
• Able to communicate to all levels within the organization.

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 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 and life sciences products and services around the globe. For more information, visit www.steris.com.

STERIS strives to be an Equal Opportunity Employer.