About You

HOW YOU WILL MAKE A DIFFERENCE

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 Engineer vacancy. This is an excellent opportunity to join the business at a skilled professional level and help us maintain and build on the excellent quality

What Is Involved

• Performs review of processing files for a new product or new specification requirements after product processing and prior to product release in order to ensure processing parameters have been met. To be responsible for product release for all processing at the site.
• Performs or facilitates the review of operating logs (spectrophotometer etc.) to ensure timely and accurate record keeping.
• Performs or facilitates the review and maintenance of calibration records to ensure calibration is performed in a timely manner.
• Establishes or facilitates the establishment of appropriate policies and procedures as well as revisions and maintenance of AST quality Systems
• Writes or assists in the writing of deviation and responses to deviations as well as documenting Customer concerns based on established Customer specification and AST policies and procedures.
• Develops corrective actions as required by process deviation, procedure deviations, complaints, regulatory audits, Customer audits and internal audits, and develops training materials and trains employees in response to procedural changes, policy changes and improvement activities.
• Prepares or facilitates the preparation of the monthly internal assessment report.
• Manages and provides deliverable or special projects such as procedure revisions. Develops vehicle and tools and concludes analysis or relevant metrics to identify areas for continuous improvement.
• Provides support in form of data, documentation and feedback for Customer and/or regulatory audits, notified body audits as well as internal audits.
• Performs internal audits at the facility and other facilities as required.
• Monitors and trends data relative to the Quality systems and makes recommendations for improvements as well as establishes implementation plans
• Maintains professional skills, knowledge and abilities by attending educational workshops, reviewing professional publications and participating in professional societies.
• Support the continuous improvement efforts within the facility by participating in quality and performance improvement projects. Provide feedback from quality staff to the Senior Quality Manager, Regional Quality Manager, Quality Manager as applicable AST and Quality and Regulatory Compliance Management on opportunities for improvement.
• Support a safe, clean and secure working environment by supporting procedures, rules and regulations; supports plant safety committees that evaluate plant machinery, equipment and working conditions.
• Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
• Exhibits a commitment to the AST shared values of Customer Satisfaction and Continuous Improvement through ensuring defect-free workmanship, assisting others to meet the Customer’s needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer’s needs with a sense of urgency.
• Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP, Lean principles and other directives; supports the directives and decisions of higher-level management and performs other duties as assigned.