Sotera Health Company

Engineering Associate II (Quality)

Sotera Health Company  •  Canada (Onsite)  •  2 months ago
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Job Description

Reporting to the Director, Quality, the Engineering Associate, applies in-depth knowledge of engineering principles and quality standards to support increased inspection workloads, develop and refine inspection criteria, and collaborate with engineering and supplier teams to ensure compliance and timely release of parts. The role is pivotal in driving inspection excellence, quality assurance, process documentation, and technical support for continuous improvement initiatives.

Key Responsibilities

  • Apply in-depth knowledge of engineering principles and standards to quality control activities.
  • Develop, implement, and regularly update inspection criteria for new and existing parts in collaboration with engineering and supplier teams.
  • Document inspections, analyze results, and support the resolution of non-conformances (NCMRs) using structured root cause analysis methods.
  • Coordinate with suppliers regarding returns, rework, and quality issues. Assist with supplier audits and provide feedback to suppliers for continuous improvement.
  • Provide technical support for process optimization and continuous improvement in inspection and quality management.
  • Ensure compliance with internal, customer, and regulatory quality requirements.

Qualifications

  • Education: Bachelor degree in Engineering (preference chemical or mechanical)
  • Experience: Minimum of two years relevant technical work experience in manufacturing process, metrological inspection, or quality assurance

Skills and Competencies

  • Proficiency in inspection, troubleshooting, and documentation of manufacturing processes.
  • Familiarity with precision machining, manufacturing equipment, and welding
  • Excellent verbal communication skills; ability to explain complex technical, regulatory, and compliance aspects to non-technical audiences.
  • Strong technical judgment and decision-making skills, especially in non-standard situations.
  • Experience providing technical recommendations to technicians and other stakeholders, , with limited oversight.
  • Effective team player with strong interpersonal and project management skills; able to handle multiple tasks and prioritize effectively.
  • Ability to identify and solve problems using standard engineering methods and techniques.
  • Experience preparing reports for distribution to various groups, outlining technical details, results, or conclusions.
  • Ability to monitor regulatory impacts on delivery of work and ensure compliance with quality standards.

Additional Requirements

  • Occasional overtime to meet project requirements
  • Occasional travel requirements

Training Required: Must complete all required training and certification as a Nuclear Energy Worker

Nordion requires pre-employment screening to be accepted as cleared prior to start date. Background verification may include the possibility of FBI fingerprinting.

Sotera Health Company

About Sotera Health Company

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.

Industry
Healthcare & Social Services
Company Size
1,001-5,000 employees
Headquarters
Broadview Heights, Ohio
Year Founded
Unknown
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