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 supporting the medical and pharmaceutical industries? Do you care about keeping patients and people safe? If so, then a career with Steris AST could be a great fit for you.

About Us:

At Steris AST we are the trusted experts in neutral sterilization offering includes radiation and gas technologies.

We offer electron beam, gamma, X-ray, ethylene oxide and vaporized hydrogen peroxide technologies for the purpose of product sterilization. Whether that product be a single use medical instrument, a hospital environment, cosmetics and toiletries, or food products, we make sure that everything that makes its way to an end user is safe for use or consumption.

We are currently recruiting for a Quality Manager vacancy. This is an excellent opportunity to join the business at a skilled professional level.

Duties

• Work in collaboration with the Lab Operations Management, Laboratory Tech Team, EO TechTeam and the Radiation TechTeam
• 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, complaints, supplier corrective action requests, deviations and OOS (Out of Specification) reports ensuring all relevant parties are informed and where appropriate, ensure appropriate corrective actions are implemented and effective.
• Facilitate Audits (Regulatory Inspections, Notified Body Assessments, Customer Audits, Supplier Audits) in collaboration with Operations Management. Ensure that the internal audit program is executed as per plan and perform audits as required.
• Manage changes to ISO 17025 accreditation scope, new or revised licenses.
• 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.

Duties - cont'd

• 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.
• Review technical documents including but not limited to equipment, methods, specifications, supplier technical agreements.
• Review Customer Quality Agreements.
• Provide and maintain service excellence to Customers; provide professionalism and courtesy at high level; attend meetings with the Customers.

Required Experience

1. Bachelor’s degree in science
2. Minimum 3 years of experience in Laboratories activities
3. Minimum 3 years of experience in Quality role
4. 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.
5. High school level of English reading, writing and verbal communication skills

1. 3 years experience and technical knowledge of equipment qualification
2. 3 years experience and technical knowledge of test method validation
3. 3 years technical experience working with testing standards

1. Effective communication skills, be a team player, and can prioritize daily activities and solve problems quickly and accurately.
2. Technical and quality writing skills
3. Knowledge and/or experience of continuous improvement programs and the medical industry would be a distinct advantage
4. Ability to handle data
5. Computer use and MS Office competence
6. 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 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.