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 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 the professional level to make difference
What is involved
Work in collaboration with the Lab Manager and the Lab Tech Team
Ensure Quality System is in compliance with STERIS procedures, standards and applicable laws
Ensure that STERIS Health and Safety Policies are correctly implemented and respected in Laboratories
In collaboration with other departments, initiate, investigate, control and analyze non-conformance reports ensuring all relevant parties are informed and where appropriate, ensure appropriate corrective action are implemented and effective.
In collaboration with other departments, initiate, investigate, control and analyze customer complaints to ensure corrective action are appropriate implemented and effective.
In collaboration with other departments, initiate, investigate, and analyze OOS (Out of Specifications) reports ensuring all relevant parties are informed and where appropriate, to ensure corrective action is implemented and effective.
Facilitate Audits (Regulatory Inspections, Notified Body Assessments, Customer Audits, Supplier Audits) in collaboration with Lab Manager. Ensure that the internal audit program is executed as per plan and perform audits as required.
Identify and report failures in the implementation of the quality system to lab manager and quality senior management. Investigate such matters and recommend appropriate corrective action.
Manage change control in conjunction with lab operations. Ensure new equipment/instruments and quality related software are qualified and requalified either periodically or after modification prior to use.
Manage and participate in local or global projects in collaboration with other departments and facilities.
Implement continuous improvement.
Monitor Laboratories performance through facilitation of quarterly facility management review.
Facilitate Quality and GMP training of all laboratory personnel; develop, support and maintain the lab employee training program.
Required Experience
Bachelor’s degree in science
Minimum 3 years of experience in Laboratories activities
Minimum 3 years of experience in Quality role
Working knowledge in a regulated industry within an operations or laboratory setting, preferably one of the following: ISO 13485, ISO 17025, ISO 9001, or other and quality management certification.
3 years experience and technical knowledge of equipment qualification
3 years experience and technical knowledge of test method validation
3 years technical experience working with testing standards
2 years experience in any capacity with extractables and leachables testing a plus, but not required
Skills
Effective communication skills, be a team player, and can prioritize daily activities and solve problems quickly and accurately.
Knowledge and/or experience of continuous improvement programs and the medical industry would be a distinct advantage
Ability to handle data
Computer use and MS Office competence
Flexibility, autonomy, accountability
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, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.
STERIS strives to be an Equal Opportunity Employer.