Regulatory Affairs jobs in Malaysia

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 Supervisor is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 11137 and and other applicable regulatory standards.

The Quality Supervisor leads a team of Technicians, Senior Technicians and Analysts/Engineers. This role owns and directs complaint/non-conformance/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. This role recommends, plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

By providing direction to the Analysts/Engineers and Technicians, the Quality Supervisor develops and manages work assignments, analyzes and trends quality system performance and is 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.

In addition, the Quality Supervisor can delegate for the Quality Manager as designated signatory when QM are not available

Duties

• Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians and Quality Analysts/Engineers by providing technical support, mentoring and oversight of assigned duties and objectives.
• Responsible for oversight of all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians and Analysts/Engineers.
• Based on facility staffing, the Quality Supervisor may be 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
• Reviews and recommends approval for protocols and final reports generated through the or EBeam Tech Center for sterilization process validations.
• Reviews the current quality system and recommend / implement improvements as needed. Develops analyses and reports on the performance of the quality system.
• Uses data to perform statistical analysis and recommend process changes to improve service quality.
• Leads the site's bowler/countermeasure process for annual quality objectives.
• Leads projects focused on quality system and service quality improvements.
• Leads and supports internal and external quality system audits including regulatory authorities, notified bodies and Customers. Performs supplier audits and internal audits at other AST facilities. Responsible for managing internal and external audit observation follow-up process for the facility.
• Leads process and product corrective actions and problem-solving activities.
• Instructs and directs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborates with other departments and facilities within the company on quality related issues.
• Travel to other AST facilities, domestically and/or globally, to support remediation activities, audits/inspections and/or continuous improvement initiatives.
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.
• Perform all other duties as assigned.
  
  

Duties - cont'd

Education Degree

Bachelor's Degree in Science

Required Experience

• 6-8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• 6-8 years of experience with medical device or other regulated industries preferred.
• 6-8 years of experience working in an ISO certified environment required.
• 2-3 years supervisory/project leadership/oversight required
• Sterilization experience preferred
• 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, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 18,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.