Job Title:  Senior Quality Manager

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 IMS could be a great fit for you.

About Us:

At Steris IMS 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 Manager vacancy. This is an excellent opportunity to join the business at Senior Level to lead our Quality Function.

The role is responsible for the organization, documentation and maintenance of the quality system to be compliant with the following standards: IS0 9001, ISO 13485, MDSAP and CFR Part 820/211, EU MDR and other applicable standards

What is involved?

Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.

Lead the organization’s Quality staff to ensure alignment to manufacturing and servicing operations, support Lean efforts and drive quality improvement for products and services.

Work closely with Senior Management to provide strategic direction and development of the organization’s quality strategies and tactics.

Provide quality viewpoints and opinions on future product and service development.

Provide coaching, mentoring and leadership to the Quality staff.

Serve as the site’s Management Representative and lead the organization’s Management Review process.

Ensure compliance with appropriate domestic regulatory and international standards and requirements.

Lead the organization's continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard.

Lead and develop effective production and process controls.

Manage the complaint handling processes to insure customer responsiveness and product and process improvements.

Ensure compliance to the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics.

Assess new designs for manufacturability, testability and reliability to ensure the Quality risks and deliverables of the New Product Development process meet the required application reliability and design intent.

Determine supplier qualification risks based upon criticality of component and supplier process capability.

The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance. 

This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) on behalf of STERIS legal manufacturing entities under the EU MDR.  This individual shall suffer no disadvantage within the organization in relation to proper fulfilment of his or her duties in lieu of article 15 of the EU MDR.

Experience and Knowledge required

Bachelors degree in Engineering , Healthcare fields or related technical field

10-15 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.

10-15 years of experience with medical device or other regulated industries preferred.

10-15 years of experience working in an ISO certified environment required.

Minimum of 6 years in a Quality leadership role.

Must fulfil the experience requirements listed in Article 15 of the EUMDR (PRRC).

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 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.