Tullamore, The Municipal District of Tullamore, Ireland · On-site
Mid level$285K raised
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Full-time
bachelor degree
Posted 31d ago
~40 hrs/week
Responsibilities
The Quality Engineer administers the quality management system to ensure adherence to ISO and FDA regulatory standards. They lead complaint and CAPA investigations, manage supplier quality, and oversee the release of processing runs containing non-conformances.
Requirements
A Bachelor's degree and 3-5 years of experience in Manufacturing/Quality Engineering within an ISO certified environment are required. Proficiency in medical device regulations and statistical techniques is strongly preferred.
Full job description
Position Summary
Please note that this is a 12 month contract position.
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.
Duties - cont'd
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.
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.
Education Degree
Bachelor's Degree
Required Experience
3-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience or minimum of 6 months on-site STERIS internship or co-op experience.
3-5 years of experience with medical device or other regulated industries preferred.
3-5 years of experience working in an ISO certified environment required.
Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
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.
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.
Related keywords
ISO 9001ISO 13485FDA 21 CFR Part 820FDA 21 CFR Part 211EU GMPISO 17025ISO 11137ISO 11135CAPAQuality Management SystemNon-conformanceInternal AuditStatistical TechniquesMedical DevicesSupplier QualityRisk Management
WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Founded
1985
Headquarters
Mentor, OH
LinkedIn followers
163,508
Total funding
$285K
STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.
MISSION
WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life science products and services around the globe.
VISION
We strive to be a GREAT COMPANY. We provide world-class products and services for our Customers, safe and rewarding work for our people, and superior returns for our Shareholders.
• $6 Billion in revenue in FY26
• More than 18,000 Associates worldwide
• Over 4,000 Customer-facing professionals
• Listed on the New York Stock Exchange under the symbol “STE”
To learn more, visit www.steris.com.
Want to join the team? View and apply for open roles at careers.steris.com.
WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Founded
1985
Headquarters
Mentor, OH
LinkedIn followers
163,508
Total funding
$285K
STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.
MISSION
WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life science products and services around the globe.
VISION
We strive to be a GREAT COMPANY. We provide world-class products and services for our Customers, safe and rewarding work for our people, and superior returns for our Shareholders.
• $6 Billion in revenue in FY26
• More than 18,000 Associates worldwide
• Over 4,000 Customer-facing professionals
• Listed on the New York Stock Exchange under the symbol “STE”
To learn more, visit www.steris.com.
Want to join the team? View and apply for open roles at careers.steris.com.