Quality Assurance Specialist

Sotera Health

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Reporting to the Director of High quality, this function is chargeable for managing and coordinating the High quality Administration System, in addition to making certain all remaining product meets Nordion’s requirements and specs. From a top quality perspective, the incumbent gives high quality management for dosimetry providers, gamma irradiation programs, and improve initiatives, manufacturing of sealed sources, and all different Nordion processes in accordance with buyer, regulatory and inner high quality necessities.

This place is deemed a Nuclear Vitality Employee (NEW). A Nuclear Vitality Employee (NEW) is outlined by the Nuclear Security and Management Act as an individual who’s required, in the middle of the particular person’s enterprise, or occupation in reference to a nuclear substance or nuclear facility to carry out duties in such circumstances that there’s a cheap chance that the particular person could obtain a dose of radiation that’s larger than the prescribed restrict for most of the people (1 mSv per 12 months for the entire physique).

Key Obligations

Ensures Nordion meets all efficiency targets and regulatory obligations to assist compliance and reliability of operations and manufactured merchandise.

Ensures Nordion’s High quality Administration Methods are absolutely carried out and regularly function inside the necessities of ISO 9001.

Administers programs akin to complaints, change management, deviation, and corrective motion and recommends actions that meet compliance requirements.

Offers high quality oversight for design, manufacturing, and set up of sealed sources and gamma irradiation programs.

Present high quality oversight for dosimetry providers to evolve to ISO/IEC 17025.

Present high quality oversight for Nordion’s software program high quality system which conforms to ISO 13485, GxP, and different applicable well being regulators.

Connects with Provider’s high quality and manufacturing representatives to make sure high quality of all equipped parts. The incumbent leads provider high quality audits of key suppliers.

Evaluations Engineering and Manufacturing investigations of non-conformances and complaints affecting product to make sure that all relevant high quality, security, and reliability necessities have been addressed.

{Qualifications}

Usually Bachelor of Science or Engineering or related self-discipline.

4 to six years’ expertise in High quality Assurance, or equivalently in engineering design, improvement and manufacturing surroundings.

Expertise and Competencies

Understands manufacturing and/or engineering principals, methodologies, and requirements. 

Understands engineering drawing practices.

In-depth understanding of the ISO 13485 and/or ISO/IEC 17025 high quality assurance requirements and the way they’re utilized. Expertise with ISO 9001 or CSA N299 could be an asset.

Good understanding of nationwide and worldwide laws and high quality requirements as anticipated by regulators akin to CNSC, US NRC, CSA, ISO and European CE mark could be an asset.

Expertise in performing or overseeing validation actions. 

Expertise in performing high quality audits, each inner and suppliers, could be an asset.

As a part of the High quality Assurance workforce, able to constructing and facilitating a top quality tradition with all staff.

Sturdy communication and interpersonal expertise.

Extra Necessities

Coaching Required: Should full all required coaching and certification as a Nuclear Vitality Employee.

The title Sotera Well being was impressed by Soteria, the Greek goddess of security, and displays the Firm’s unwavering dedication to its mission, Safeguarding International Well being®. Sotera Well being Firm is a number one international supplier of mission-critical sterilization and lab testing and advisory providers for the healthcare trade. With a mixed tenure throughout our companies of practically 200 years and our trade acknowledged scientific and technological experience, we assist to make sure the protection of tens of millions of sufferers and healthcare practitioners all over the world yearly. Throughout our 64 amenities worldwide, we now have over 3,000 staff who’re devoted to security and high quality. We’re a trusted companion to greater than 5,800 prospects in over 50 international locations, together with greater than 40 of the highest 50 medical gadget firms and eight of the highest 10 international pharmaceutical firms. 

Sotera Well being goes to market by means of its three best-in-class companies – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a number one international supplier of outsourced terminal sterilization and irradiation providers for the medical gadget, pharmaceutical, meals security and superior functions markets. Nordion is the main international supplier of Co-60 and gamma irradiators, that are key parts to the gamma sterilization course of. Nelson Labs is a world chief in outsourced microbiological and analytical chemistry testing and advisory providers for the medical gadget and pharmaceutical industries. Be taught extra about Sotera Well being at soterahealth.com. 

Nordion is a number one international supplier of Cobalt-60 used within the sterilization and irradiation processes for the medical gadget, pharmaceutical, meals security, and high-performance supplies industries, in addition to within the therapy of most cancers. Nordion provides merchandise to greater than 40 international locations all over the world. Be taught extra about Nordion at www.nordion.com.

Safeguarding International Well being® – with each Cobalt-60 supply we provide.

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