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

• 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.

Duties

• 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 ar met according to documented policies, procedures, standards and regulations.
• Perform other duties as assigned.

Duties - cont\'dEducation DegreeBachelor\'s Degree in Science or Biological ScienceRequired Experience

• 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• 1-5 years of experience with medical device or other regulated industries preferred.
• 1-5 years of experience working in an ISO certified environment required.
• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.

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.If you need assistance completing the application process, please call 1 . This contact information is for accommodation inquiries only and cannot be used to check application status.STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.The full affirmative action program, absent the data metrics required by \xc2\xa7 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location\'s HR Office during normal business hours.Req ID: 43870Job Category: QualityKuala Ketil, 02, MY, 09300

Steris