About this role
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.
Our site in Komenda is home to advanced manufacturing technologies and a team committed to excellence, innovation, and continuous improvement.
We are looking for an experienced Quality Manager to lead our Quality function and ensure compliance with global regulatory requirements and industry standards. As a member of the site leadership team, you will play a key role in driving quality performance, continuous improvement, and operational excellence across the organization.
What you'll do
- ✓Lead and develop the site Quality team, ensuring compliance with the Quality Management System and fostering a culture of continuous improvement.
- ✓Partner closely with Operations and other functions to improve product quality, process performance, and customer satisfaction.
- ✓Provide strategic quality leadership and contribute to the development of quality strategies and initiatives.
- ✓Serve as the site's Management Representative and lead the Management Review process.
- ✓Ensure compliance with applicable standards and regulations, including ISO 9001, ISO 13485, MDSAP, CFR Part 820/211, EU MDR, and other relevant requirements.
- ✓Drive continuous improvement through data analysis, quality metrics, process capability assessments, and improvement projects.
- ✓Lead the implementation and maintenance of effective production and process controls.
- ✓Oversee complaint handling processes to ensure timely customer responsiveness and support product and process improvements.
- ✓Support New Product Development activities by ensuring quality requirements, manufacturability, testability, reliability, and regulatory expectations are incorporated throughout the development process.
- ✓Assess supplier qualification risks and support supplier quality initiatives.
- ✓Act as Person Responsible for Regulatory Compliance (PRRC) in accordance with EU MDR requirements.
- ✓Coach, mentor, and develop Quality team members while collaborating effectively with site and global leadership teams.
What we're looking for
Required Qualifications
- ✓Bachelor's degree in Engineering or another technical field.
- ✓8 years of experience in Quality Engineering, Quality Systems, Manufacturing Quality, or a related discipline.
- ✓Experience working in an ISO-certified and regulated manufacturing environment.
- ✓Minimum of 2 years of experience in a Quality leadership role.
- ✓Eligibility to fulfil the experience requirements of Article 15 of the EU MDR (PRRC).
Preffered Qualifications
- ✓Experience in the medical device industry or another highly regulated industry.
- ✓Knowledge of QSR, GMP, MDR, and related regulatory requirements.
- ✓ASQ certification or equivalent quality qualifications.
- ✓Experience with statistical analysis tools and continuous improvement methodologies.
What Will Make You Successful
- ✓Strong problem-solving and analytical skills.
- ✓A proactive approach to identifying opportunities for improvement.
- ✓Ability to work effectively across cross-functional teams.
- ✓Excellent organizational, written, and verbal communication skills.
- ✓Strong leadership, coaching, and people development capabilities.
- ✓Confidence in balancing strategic priorities with operational execution.
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.