Position Summary
Join a company where the work you do makes a difference! We are One Team with One Goal. At STERIS Applied Sterilization Technologies (AST), it’s our philosophy and our way of doing business. Through a network of over 50 facilities globally, STERIS AST has been committed to providing contract sterilization services to the medical device, pharmaceutical, consumer, and industrial communities for over 40 years. Our irradiation and gas sterilization services ensure the safety of those who use these products, including our families, our friends, and ourselves. If you are looking to join a collaborative and innovative team in an essential industry, apply for our Quality Analyst position today!
The Quality Analyst plays a key role in maintaining and improving the siteās Quality Management System, ensuring compliance with ISO standards, FDA regulations, and other applicable requirements. You will lead investigations such as complaints and CAPA, while driving supplier quality and continuous improvement initiatives using data-driven methods. You will also support production by managing non-conformance reviews and processing run approvals. Additionally, the QA Analyst ensures all product processing activities meet customer and regulatory requirements, including audits, validations, testing, and documentation.
Please note that this is a full-time/permanent and fully on-site position in our facility located in Sainte-Anne-de-Bellevue, QC.
What You'll Do as a Quality Analyst at STERIS
- Coordinate day-to-day tasks and direction for Quality Technicians by providing technical support, mentoring and oversight.
- Responsible for oversight of all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians.
- Responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading the associated non-conformance investigations.
- Initiate and/or participate in corrective actions, problem-solving and continuous improvement activities.
- Perform internal audits at other AST facilities, including identification of non-compliances and report generation.
- Responsible for managing remediation of internal audit observations assigned by site Quality Manager.
- Manage creation of new quality system policies and procedures and revisions to existing policies/procedures.
- Review collected data to perform statistical analysis and recommend process changes to improve quality.
- Monitor and report on performance metrics. 9. Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
- Collaborate with other departments and facilities within the company on quality related issues.
- Lead quality system programs (i.e. calibration, maintenance, training, CAPA, complaints, non-conformances, supplier quality, management review, operational qualifications, document control, change control, risk management, etc).
- Overall responsibilities include commitment to ensure external and internal requirements ar met according to documented policies, procedures, standards and regulations.
- Perform other duties as assigned.
The Experience, Skills and Abilities Required
Required
- Hold a Bachelor's degree in a scientific or related technical field.
- Have at least 3 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- Must be bilingual in English and French (spoken and written).
- Excellent problem-solving skills.
- Focus on identification of potential issues and continuous improvement.
- Experience working on cross-functional teams and on own initiative.
- Demonstrated excellent organizational, oral and written communications skills.
- Proficient in computer and mathematical skills.
- Ability to work in a fast-paced, regulated environment with strict deadlines.
Preferred
- Previous experience in pharmaceutical, medical device or cannabis industry are strongly preferred.
- Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
What STERIS Offers
At STERIS, we offer a stimulating work environment with real opportunities for advancement! STERIS is a well-established company operating in the medical equipment field, specifically in decontamination, sterilization, and other infection prevention technologies. This field directly impacts peopleās health, which is why we make sure to surround ourselves with a rigorous team that adheres to the highest quality standards.
WHAT WE OFFER:
- Competitive compensation;
- A range of employee benefits, including:
- A comprehensive and flexible group insurance plan – offering various options and approximately 90% covered by STERIS. This plan includes prescription drug coverage, vision care, paramedical services, and dental care;
- Telemedicine services;
- An Employee Assistance Program (EAP);
- A bank of personal days (5 days);
- A schedule of 12 holidays (including 8 statutory holidays);
- A day off on your work anniversary;
- A group RRSP with employer contributions from STERIS, up to 3% of annual salary;
- A corporate bonus program;
- An experienced and multidisciplinary team;
- A safe environment at the forefront of continuous improvement.
This position requires knowledge of English due to the nature of the duties involved, including regular communications outside the province of Quebec, training, email communications, and frequent meetings and interactions with English-only employees. The employer has taken all reasonable steps to avoid imposing this language requirement, in accordance with the Charter of the French Language.
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 and life sciences products and services around the globe. For more information, visit www.steris.com.
STERIS strives to be an Equal Opportunity Employer.
