Quality Analyst

5 months ago

Edmonton, Canada STERIS Full time

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 is responsible for assisting in administration of the quality management system at a site 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. This role 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. 

Duties

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 (. 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.

#LI-BB1

Required Experience

Bachelor's Degree. 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience. 1-5 years of experience working in an ISO certified environment.

Preferred Experience

Working knowledge of FDA QSR/ EUGMP regulations strongly preferred. 1-5 years of experience with medical device or other regulated industries preferred.

Skills

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. Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint. Ability to work in a fast-paced, regulated environment with strict deadlines. Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra.

Work Schedule

This is an onsite schedule position. The schedule is: M-F, dayshift hours.  5% - 10% international and domestic travel. 

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, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.

  • Quality Assurance Analyst

    2 weeks ago

    Edmonton, Canada GTT, LLC Full time

    Job Title: Quality Assurance AnalystPosition: ContractDuration: 11 months (with high probability of extension)Job Description:Our client is a National firm in Investment Management and is considered a leading instutition in the Financial Services industry as one of Canada's largest organizations. They are looking to hire Quality Assurance Analysts who...

  • Quality Assurance Analyst

    4 weeks ago

    Edmonton, Canada City of Edmonton Full time

    **Job Number**:50885** The Community Investment Section of the Social Development Branch is looking for highly skilled and experienced Quality Assurance Analysts to join their team. Reporting to an Evaluation Analyst, this position is vital to the Community Funding Strategies team. If you're passionate about delivering high-quality research and analysis,...

  • Quality Assurance Analyst

    4 weeks ago

    Edmonton, Canada Alata: Forward-Focused Fleet Solutions Full time

    At Alata we work for the good of the product which in turn serves our customer and drives their success. Our work revolves around two areas: building out our Alata LINKproduct as well as supporting clients with their application development efforts. We work with an interest in growth – of our skillsets, our product, our customers, our team and ourselves....

  • Quality Assurance Analyst

    6 months ago

    Edmonton, Canada PipeCom Full time

    PipeCom is seeking a dynamic Quality Assurance Analyst to join our experienced team of problem solvers. **Minimum Job Qualifications** - Post-secondary degree in computer science, software engineering, or related fields. - 3-5 years’ experience as a QA automation specialist. - Ability to work independently and as part of a team, managing multiple tasks...

  • Quality Assurance Analyst

    1 month ago

    Edmonton, Alberta, Edmonton region, Canada Alata: Forward-Focused Fleet Solutions Full time

    At Alata we work for the good of the product which in turn serves our customer and drives their success. Our work revolves around two areas: building out our Alata LINKproduct as well as supporting clients with their application development efforts. We work with an interest in growth – of our skillsets, our product, our customers, our team and ourselves....

  • Software Quality Assurance Analyst

    3 weeks ago

    Edmonton, Alberta, Canada Binary Consulting Inc. Full time

    Job SummaryAt Binary Consulting Inc., we are seeking a skilled Software Quality Assurance Analyst to join our team. As an Application Tester Specialist, you will be responsible for developing and documenting software testing plans, installing software and hardware, and configuring operating system software in preparation for testing.Key...

  • Analyst

    6 months ago

    Edmonton, Canada Labstat International Inc. Full time

    Labstat International Inc./Labs-Mart Inc. Inc. is an independent third-party testing laboratory that provides analytical services to the supplement, food and cannabis industry. Labstat International Inc./Labs-Mart Inc. Edmonton is a cGMP certified analytical laboratory and carries ISO 17025 accreditation. **We are seeking a 18 month Contract **Analyst I -...

  • Quality Assurance Professional

    2 weeks ago

    Edmonton, Alberta, Canada GTT, LLC Full time

    Job Title: Quality Assurance AnalystCompany Overview:GTT, LLC is a National firm in Investment Management and is considered a leading institution in the Financial Services industry as one of Canada's largest organizations.About the Role:We are seeking a detail-oriented and highly motivated Quality Assurance Analyst to support our testing efforts by reviewing...

  • IT Integration Analyst

    7 months ago

    Edmonton, Canada Civeo Full time

    Civeo is a global workforce accommodation specialist that helps people maintain healthy, productive and connected lives while living and working away from home. Our unique approach focuses on guest wellbeing, operational efficiency, community building and a property development mindset - making us a leading provider of accommodation solutions. Civeo Canada...

  • Sustainability Analyst

    6 months ago

    Edmonton, Canada Stantec Full time

    Sustainability Analyst - ( 240001QR ) Description Stantec's Western Canada Carbon Impact Team is a collaborative and creative group of multi-disciplinary sustainability, health and wellbeing and energy professionals. We provide professional consulting services that support high quality, healthy and

  • Systems Analyst

    6 months ago

    Edmonton, Canada CB Canada Full time

    Systems Analyst - SAPOn behalf of our client, Procom is seeking a Systems Analyst - SAP for a 13 months contract in Edmonton, Alberta.Systems Analyst - SAP Job DetailsThe System Analyst is accountable for providing technical designs and delivering solutions for the SAP Billing and Bill Print area for the SAP operational functional team. This includes...

  • Senior Quality Assurance Director

    3 weeks ago

    Edmonton, Alberta, Canada S.i. Systèmes Full time

    S.i. Systèmes is seeking a highly experienced Senior Quality Assurance Manager to lead our quality assurance efforts in Edmonton, AB.We are offering an estimated salary of $120,000 - $150,000 per year, commensurate with experience.Job Description:Our ideal candidate will have 8+ years of experience as a Quality Assurance Analyst and have previously worked...

  • Laboratory Analyst

    6 months ago

    Edmonton, Canada EMSL Full time

    EMSL Canada is seeking a full time **Laboratory Analyst (Asbestos) **in **Edmonton, AB. **No laboratory experience is required, just a desire to learn technical skills and become proficient in common laboratory practices and procedures. On-the-job training will be provided for all new employees. Experienced analysts are welcomed to apply. **Responsibilities...

  • IT Business Analyst

    3 weeks ago

    Edmonton, Canada Martin Recruitment Inc. Full time

    Position: Permanent Location: Acheson, AB Work Model: On Site, Monday-Friday **Martin Recruitment is working with a client base in search for an IT Business Analyst to join their dynamic Team!** The IT Business Analyst will develop and lead the overall technology vision and roadmap for the Company, focusing on supporting business operations and fostering...

  • Laboratory Analyst

    6 months ago

    Edmonton, Canada EMSL Full time

    EMSL Canada, one of the largest environmental testing firms in North America, is currently seeking a full time **Laboratory Analyst** specializing in Asbestos analysis for its Edmonton, AB laboratory location. This position offers a very competitive pay rate for trained asbestos analysts from competitor laboratories and the chance to work for a stable...

  • Data Analyst Manager

    2 weeks ago

    Edmonton, Alberta, Canada Miniso Full time

    About the RoleWe are seeking a highly skilled Data Analyst Manager to join our team at Miniso.Job SummaryThis is an exciting opportunity for a seasoned Data Analyst Manager to lead and manage data analysis activities across various business functions. The successful candidate will be responsible for developing and implementing data-driven strategies, driving...

  • Junior Business Analyst

    3 months ago

    Edmonton, Canada Cadence Solutions Full time

    **Reporting To**:Manager - Business Solutions **Overview** As a Junior Business Analyst, you will be involved with client projects, including but not limited to design, configuration, testing, training, and support. You will assist the Senior Business Analyst, project manager, and the technical analysts in the gathering and defining of client requirements...

  • Junior Business Analyst

    2 months ago

    Edmonton, Canada Cadence Solutions Full time

    **Reporting To**:Manager - Business Solutions **Overview** As a Junior Business Analyst, you will be involved with client projects, including but not limited to design, configuration, testing, training, and support. You will assist the Senior Business Analyst, project manager, and the technical analysts in the gathering and defining of client requirements...

  • Analyst

    5 months ago

    Edmonton, Canada NORQUEST COLLEGE Full time

    **Job Description**: **ANALYST** **FACULTY OF SKILLS & FOUNDATIONAL LEARNING** NorQuesters are difference makers and we’re searching for someone dedicated to finding ways forward to join our Faculty of Skills & Foundational Learning as an Analyst. The Analyst reports to the Manager, Business Planning, and supports the Leadership team within the Faculty...

  • Lab Analyst

    6 months ago

    Edmonton, Canada Labstat International Inc. Full time

    Labstat International Inc./Labs-Mart Inc. Inc. is an independent third-party testing laboratory that provides analytical services to the supplement, food and cannabis industry. Labstat International Inc./Labs-Mart Inc. Edmonton is a cGMP certified analytical laboratory and carries ISO 17025 accreditation. **We are seeking a full-time Analyst/Senior Analyst...