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.
The Document Management & QA Support Coordinator, reporting to the Director Quality, reviews and verifies that engineering drawings, bills of material, and configuration management meet internal requirements.
Working within the Quality function and closely with Engineering, the role supports drawing releases, engineering changes, and configuration management process to ensure technical information is accurate, current, traceable, and properly controlled.
The position also supports document management and broader QA activities within the Quality Management System (QMS), including the control and maintenance of documents within MasterControl.
Key Responsibilities
- Ensure engineering documents, drawings, product structures and related documentation meet established quality and configuration management requirements prior to release.
- Utilize Product Data Management (PDM) systems to review and ensure accuracy of engineering drawings, bills of material and configuration-related information.
- Support engineering change activities, new product introductions and product updates through effective document and configuration control.
- Manage the creation, revision, approval and distribution of controlled documents using electronic document management systems.
- Troubleshoot document and configuration-related issues and support users with document management and workflow processes.
- Maintain quality and regulatory records in accordance with established requirements.
- Support Quality activities including document reviews, complete internal and supplier audits, maintenance of quality databases and reporting activities.
- Maintain and trend quality-related data and prepare routine reports and metrics.
Qualifications
Post-secondary education in Engineering Technology, Records and Information Management, Quality, Business Administration or a related discipline.
3-5 years of experience supporting configuration management, drawing control, engineering change management, and Product Data Management (PDM) within a manufacturing or engineering environment.
Experience working with electronic document management systems (eg Quality Management Systems and/or Product Data Management systems.)
Experience supporting engineering documentation, controlled drawings, bills of material and engineering change processes.
Experience in a manufacturing, technical or regulated environment.
Familiarity with ISO 9001, ISO 13485, ISO/IEC 17025 or CSA N299 quality systems is an asset.
Experience conducting audits and managing QMS metrics is a strong asset.
Skills and Competencies
Strong attention to detail and commitment to the accuracy and integrity of drawings and configuration information.
Ability to work independently, manage competing priorities, and make sound decisions within established requirements.
Confidence to ask challenging questions, identify inconsistencies, and escalate concerns when information or requirements are unclear.
Strong analytical, problem-solving, organizational, and communication skills.
Ability to collaborate effectively with key stakeholders.
Advanced proficiency with Microsoft Word, (formatting and maintaining complex documents).
Experience with MasterControl, Autodesk Vault or similar document/PDM systems is essential.
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.
