The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Study Director I/II – Scientific Project Management & Client Services
Salt Lake City, Utah, United States · On-site
Mid level$3.8B raised
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Scientific Project Management, Customer Relationship Management, Technical Writing, Data Analysis, Good Documentation Practice
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Electromechanical Troubleshooting, Sterilization Process Operation, Technical Documentation, Data Management, Critical Thinking
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Triage, Sample Handling, Data Entry, Microsoft Office, Microsoft Outlook
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Consulting Study Director – Extractables & Leachables
Salt Lake City, Utah, United States · Hybrid
Senior$3.8B raised
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Study Consulting, Regulatory Compliance, Project Management, Customer Service, Test Protocol Development
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Customer Service, Administrative Support, Microsoft Office Suite, Communication Skills, Organization
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Leadership, Change Management, Union Relations, Time Management, Performance Management
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Forklift Operation, Shipping And Receiving, Inventory Management, Data Entry, Computer Proficiency
Charlotte, North Carolina, United States · On-site
Entry level$3.8B raised
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: System Monitoring, Equipment Maintenance, Forklift Operation, Process Documentation, Safety Compliance
Charlotte, North Carolina, United States · On-site
Entry level$3.8B raised
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: System Monitoring, Equipment Maintenance, Forklift Operation, Process Documentation, Safety Compliance
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Town of Queensbury, New York, United States · On-site
$134k–$227k/yr
Senior+$3.8B raised
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Allen Bradley, Rockwell PLCs, Aveva InTouch, PLC Control, SCADA Systems
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time
bachelor degree
Posted 33d ago
~40 hrs/week
Responsibilities
Manage and coordinate the Quality Management System to ensure all final products meet standards and specifications. Provide quality leadership for dosimetry services, gamma irradiation systems, and Co-60 sealed source manufacturing.
Requirements
Requires a Bachelor of Science or Engineering with 4 to 6 years of experience in Quality Assurance or a manufacturing environment. Must be capable of completing certification as a Nuclear Energy Worker and possess in-depth knowledge of ISO quality standards.
Full job description
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.
Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
Reporting to the Director of Quality, this role is responsible for managing and coordinating the Quality Management System, as well as ensuring all final product meets Nordion’s standards and specifications. From a quality perspective, the incumbent provides quality leadership for dosimetry services, gamma irradiation systems projects and parts, Co-60 sealed source manufacturing, and all other Nordion processes in accordance with customer, regulatory and quality requirements.
This position is deemed a Nuclear Energy Worker (NEW). A Nuclear Energy Worker (NEW) is defined by the Nuclear Safety and Control Act as a person who is required, in the course of the person’s business, or occupation in connection with a nuclear substance or nuclear facility to perform duties in such circumstances that there is a reasonable probability that the person may receive a dose of radiation that is greater than the prescribed limit for the general public (1 mSv per year for the whole body).
Key Responsibilities
Ensures Nordion meets all performance targets and regulatory obligations to support compliance and reliability of operations and manufactured products.
Ensures Nordion’s Quality Management Systems are fully implemented and continually operate within the requirements of ISO 9001.
Administers systems such as non-conformance, complaints, change control, deviation, and corrective action and recommends actions that meet compliance standards.
Provides quality oversight for design, manufacturing, and installation of sealed sources and gamma irradiation systems.
Provide quality oversight for dosimetry services to conform to ISO/IEC 17025.
Connects with Supplier’s quality and manufacturing representatives to ensure quality of all supplied components. The incumbent leads supplier quality audits of key suppliers.
Reviews Engineering and Manufacturing investigations of non-conformances and complaints affecting product to ensure that all applicable quality, safety, and reliability requirements have been addressed.
Qualifications
Normally Bachelor of Science or Engineering or relevant discipline.
4 to 6 years’ experience in Quality Assurance, or equivalently in engineering design, development and manufacturing environment.
• In-depth understanding of the ISO 9001 and/or ISO/IEC 17025 quality assurance standards and how they are applied. Experience with ISO 13485 or CSA N299 would be a strong asset.
• Good understanding of national and international regulations and quality standards as expected by regulators such as CNSC, US NRC, CSA, ISO and European CE mark would be an asset.
Experience in performing or overseeing validation activities.
Experience in performing quality audits, both internal and suppliers, would be an asset.
As part of the Quality Assurance team, capable of building and facilitating a quality culture with all employees.
Strong communication and interpersonal skills
Additional Requirements
Training Required: Must complete all required training and certification as a Nuclear Energy Worker.
Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.
Related keywords
Quality AssuranceISO 9001ISO/IEC 17025ISO 13485CSA N299CNSCUS NRCCSAEuropean CE MarkNuclear Energy WorkerGamma IrradiationCo-60DosimetrySupplier AuditsNon-conformanceCorrective Action
Sotera Health brings together Sterigenics, Nelson Labs and Nordion, each of which are established, highly reputable players in the global health arena. Working as a team, Sotera Health and its companies have one common goal: Safeguarding Global Health®. With these three companies operating together, Sotera Health, formerly Sterigenics International, leverages more than 500 combined years of scientific expertise to ensure safety across the medical device, pharma, tissue and food industries. With over 2,800 employees globally, including more than 350 scientists, the company operates 63 facilities worldwide across 13 countries. Our purpose is bigger than the products and services we provide. We ensure that health care around the world is consistently and reliably safe every day. Our purpose, our conduct, and our values are at the heart of our commitment to employee safety, environmental responsibility, and sustainability principles.
The Sotera Health name is new, but our track record for reliability and safety in global health is well established. Formed in 2017 as the parent company for Nelson Labs, Nordion and Sterigenics, Sotera Health is the leader in protecting global health thanks to the longstanding reputation for quality across each of its companies. In aggregate, Sotera Health has over 185 years of combined industry leadership. Sterigenics has provided safe sterilization services since the 1930s. Nordion has established expertise in gamma technologies and medical isotopes since 1946. Nelson Labs has provided expert lab testing since 1985. Our most recent addition to the Sotera Health family, Toxikon Europe, has established a leading extractables and leachables testing platform since 1990. An impressive history that points to an even brighter future.
Offices: 9100 South Hills Blvd, Suite 300, Broadview Heights, Ohio 44147, US
Safeguarding Global HealthSterilization TechnologiesLab TestingAdvisory Servicesand Sterilization SolutionsHealth CareMedical DeviceBiotechnology
Sotera Health brings together Sterigenics, Nelson Labs and Nordion, each of which are established, highly reputable players in the global health arena. Working as a team, Sotera Health and its companies have one common goal: Safeguarding Global Health®. With these three companies operating together, Sotera Health, formerly Sterigenics International, leverages more than 500 combined years of scientific expertise to ensure safety across the medical device, pharma, tissue and food industries. With over 2,800 employees globally, including more than 350 scientists, the company operates 63 facilities worldwide across 13 countries. Our purpose is bigger than the products and services we provide. We ensure that health care around the world is consistently and reliably safe every day. Our purpose, our conduct, and our values are at the heart of our commitment to employee safety, environmental responsibility, and sustainability principles.
The Sotera Health name is new, but our track record for reliability and safety in global health is well established. Formed in 2017 as the parent company for Nelson Labs, Nordion and Sterigenics, Sotera Health is the leader in protecting global health thanks to the longstanding reputation for quality across each of its companies. In aggregate, Sotera Health has over 185 years of combined industry leadership. Sterigenics has provided safe sterilization services since the 1930s. Nordion has established expertise in gamma technologies and medical isotopes since 1946. Nelson Labs has provided expert lab testing since 1985. Our most recent addition to the Sotera Health family, Toxikon Europe, has established a leading extractables and leachables testing platform since 1990. An impressive history that points to an even brighter future.
Offices: 9100 South Hills Blvd, Suite 300, Broadview Heights, Ohio 44147, US
Safeguarding Global HealthSterilization TechnologiesLab TestingAdvisory Servicesand Sterilization SolutionsHealth CareMedical DeviceBiotechnology