Job Title:  Site Radiation Validation & RTC Manager

Req ID:  40637
Job Category:  Service/Technical Services

Bradford, BRD, GB, BD4 6SE

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.

Position Summary

Role is primarily responsible for technical activities in the Site related to Radiation Technology and RTC. Person in this role will be recognized as the primary subject matter expert & leader in the site with regard to Radiation Technology included dosimetry system, irradiator qualification and product qualification. Indirect report line to the RTC Manager when applicable

Duties

Customer Performance Qualification (30%) • Responsible for Customer PQ (Protocol, Dosimeter placement, Report) activities according to WI • Coordinate all PQ validation and special request activities as the primary point of contact at the site for Customer(s), Account Manager(s) and TechTeam. • Evaluate process capability of a given product before start of PQ activities and after data analyzis • Prioritize and Schedule product validation activities (e.g. dose mapping, samples processing, quarterly dose audit) in collaboration with Sales, Operations • Track PQ activities at each step of the process once PQ activities has been approved by Customer: Process of tracking PQs includes, but is not limited to, the following: o Ensure PO is available. o Ensure Protocol is completed and approved. o Coordinate delivery product for PQ with Customer. o Schedule (prioritization / queue) PQ runs o Coordinate execution of PQ runs o Data analysis o final report completion o Implementation routine processing in coordination with Plant Quality Manager • Provide feedback to Sales at each step as required/requested. • Delivery of highest levels of Customer satisfaction • Ensure the respect of deadlines agreed with customers

Specific TO RTC

Specific to RTC (30%) • Operational lead for RTC activities • Ensure the RTC Maintaining a safe, clean, secure working environment. • Support RTC Technicians on new product set-up/processing, particulary those which do not meet the standard dose mapping families. • Support RTC Technicians on RTC scheduling  2 • Manage the treatment of products (follow the respect of deadlines, define the processing parameters, plan the treatments in collaboration with the planner, replace the planner in case of absence) • Optimize and maximize the use rate of the irradiator, • Supporting the RTC Customer Support as primary contact for Customers to answer to their question and to define specific processes (e.g : low dose rate, temperature, nuclear or space industry) • Responsible for radiation facility qualification (IQ,OQ): o Qualify dose rate at different location o Qualify different location

Radiation Technical Support & Guidance (15%)

Ensure that all technical procedures and work instructions (local and global) are fully implemented and complied with. • Directs and supports the site business in matters such as harmonized policy and procedure development; best practice sharing; training & development initiatives. • Support Quality Team in document review (qualification, WI) and in technical assessment of critical supplier (Ebeam, Cobalt, X-Ray supplier, dosimetry) • Support Quality team during non-conformance investigation with technical input as required • Responsible for radiation facility qualification (IQ,OQ) according to WI • Direct technical support to Customers as required. • Monitor routine process (Statistical Process Control) • Maintain all aspects of the Quality system and records to appropriate quality standards • Support production in special process activities (Dose Audit, Maximal dose testing) • Reporting of technical updates (e.g. Technical NC’s; Dosimeter issues; Customer PQ issues) to Regional Validation Manager • Ensuring compliance to relevant standards, regulations and STERIS Policies

Management (15%)

Supervise site Radiation Technology team, including RTC (GPS, Talent review, Irewards, vacation) • Responsible for site validation team training • Facility Management review • Responsible for KPI report • Responsible to define validation department budget

Dosimetry System (10%)

Support or coordinate dosimetry System qualification, calibration and maintenance activities (Protocol, Treatment, Report, Verification, Cleaning) in accordance to WI • Ensure dose measurement activities are performed according to WI (e..g: Laboratory environment control) • Monitoring re-reads and reporting stats on monthly basis to Regional Validation Manager • Support the site in case of equipment failure. • Maintain all aspects of the Quality system and records to appropriate quality standards • Perform training dosimetry reader. • Manage site dosimeter stock (Incoming inspection, storage, consumption… • Responsible for low or high dose range dosimetry calibration for RTC

Skills

1. Ability to demonstrate mathematical and technical competence for problem solving.

2. Proficient in use of MS Excel, MS Word

3. Academic knowledge of Quality Systems and working in a regulated environment.

4. Academic knowledge of Good Documentation Practices (GDP) 

5. Team Management

1. Ability to effectively read, write and verbally communicate in English.

2. Ability to work under general direction of a supervisor or senior team member.

3. Ability to work well with others.

4. Above average organizing, analyzing and math skills (advanced algebra and/or calculus and/or statistics) to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.

5. Ability to adapt to changing duties and responsibilities.

6. Normal hearing range sufficient to hear alarms, bells, horns, etc.

 

 

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.  

Req ID:  40637
Job Category:  Service/Technical Services

Bradford, BRD, GB, BD4 6SE


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