Quality Analyst
Quality Analyst
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Job Description
At STERIS we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary
The Quality Analyst in the STERIS Applied Sterilization Technologies (AST) Edmonton Alberta Canada location is responsible for assisting in administration of the quality management system to assure adherence to ISO 9001 ISO 13485 FDA 21 CFR Part 820/211 EU GMPs ISO 17025 ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Quality Analyst leads complaint/CAPA investigations supplier quality improvement initiatives continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. This role executes activities concerned with the development implementation maintenance and continuous improvement of STERIS quality systems.
The Analyst also supports production and quality operations by coordinating and performing problem-solving investigations pre-reviews and final acceptance/run release of processing runs that contain non-conformances. Responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations dosimetry results generation of test methods audits scheduling validations record keeping and reporting.
This position requires working onsite in our Edmonton Alberta Canada location Monday Friday 7am to 4pm or 8am to 5pm.
What Youll do as a Quality Analyst
- Coordinate day-to-day tasks and direction for Quality Technicians/Senior 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.
- 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 are met according to documented policies procedures standards and regulations.
- Perform other duties as assigned.
The Experience Skills and Abilities Needed
Required:
- Bachelors degree in Scientific or Technical Field.
- Minimum of 1 year of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- Minimum of 1 year of experience working in an ISO certified environment required.
Preferred:
- Minimum of 1 year of experience with medical device or other regulated industries preferred.
- Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
- Familiarity with Cannabis industry.
Other:
- 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.
- Ability to work in a fast-paced regulated environment with strict deadlines.
- Must have PC experience as well as working familiarity of desktop applications including Excel Word and PowerPoint. Mathematical skills including practical application of fractions percentages ratios proportions and algebra.
What STERIS Offers
We value our employees and are committed to providing a comprehensive benefits package that supports your health well-being and financial future.
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#LI- Onsite
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 .
STERIS strives to be an Equal Opportunity Employer.
Required Experience:
IC
Employment Type
Full Time
