Manager, Quality

STERIS; Syston; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global provider of healthcare solutions is seeking a Quality Manager in Syston, England. This role involves leading quality improvement initiatives, ensuring compliance with regulatory standards, and managing quality staff. Candidates should have 7-10 years of experience in quality engineering, especially within medical devices, and a bachelor’s degree is required. This position offers an opportunity to make a significant impact in ensuring quality across products and services.

Qualifications

• 7-10 years of Manufacturing/Quality Engineering experience.
• Experience in medical device or regulated industries is preferred.
• 7-10 years in an ISO certified environment required.
• Minimum of 3 years in a Quality leadership role.
• Must fulfil Article 15 of the EUMDR (PRRC) experience requirements.

Responsibilities

• Lead the Quality staff and ensure compliance with the Quality Management System.
• Work closely with management to develop quality strategies.
• Manage the complaint handling processes and ensure product improvements.
• Lead the organization's continuous improvement process.
• Ensure compliance with domestic and international standards.

Skills

Excellent problem-solving skills

Continuous improvement focus

Cross-functional teamwork

Organizational, oral and written communication skills

PC experience with Excel, Word, PowerPoint

Statistical analysis software familiarity

Education

Bachelor's degree

Tools

Excel

Word

PowerPoint

Statistical analysis software

Visio

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

About you: Do you want to spend your working time making a difference in the world around you? Are you motivated by impactful work? If so, then a career with STERIS 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 a Quality Manager vacancy. This is an excellent opportunity to join us at senior level in a division that drives the business forwards through innovation.

The Quality Manager will be responsible for leading quality improvement for a manufacturing or service facility/function. This position leads implementing and maintaining state-of-the-art quality practices for associated product and service lines

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 site 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 implement 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.

Required Experience

• 7-10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• 7-10 years of experience with medical device or other regulated industries preferred.
• 7-10 years of experience working in an ISO certified environment required.
• Minimum of 3 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
• Bachelor’s degree

Skills

• 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.