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- Support new product variant development and new processes and changes to existing processes following change management and risk management procedures, ensuring compliance to regulations and standards requirements.
- Review Manufacturing Plan, Site Validation Master Plan, Equipment's REQ, SPEC, Drawing, Process Validation Protocol and report, WI, DHR etc
- Support cross-functional teams in the development, update, and release of risk management documentation inclusive of but not limited to: Hazard Analysis, Risk Management Plan & Report, FMEA's (Use, Design & Process), Fault Tree Analysis.
- Support development team in creation, review and approval of engineering test protocols and reports in support of design control and process validation.
- Support development team in creation, review, and approval of traceability of user requirements, engineering specifications, and verification & validation testing.
- Lead measurement systems analysis for acceptability and develop, support, & approve validation protocols and reports for test methods.
- Define statistical testing methods and sampling in support of verification and validation testing.
- Accountable to assess, develop, write and implement protocols as needed for improved testing and quality of product including new product variant validation protocols.
- Ensure the ongoing readiness for and participate in any potential internal/external audits and inspections.
- Participate in problem solving and other work improvement activities.
- Comply with the ISO14001 Environmental Management System policy, SOP and requirements
- Continuous support to the development and implementation of program to achieve and maintain the ISO 14001 environmental management system.
- Perform other tasks as required.
- Bachelor's Degree in Science / Engineering or equivalent
- 3-5 years or more years working in Medical Device/ pharmaceutical GMP manufacturing facility in a Quality Assurance or related capacity and knowledge of process validation
Senior Quality Systems Engineer - Simpang Ampat, Malaysia - Haemonetics
Description
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.
Job Details
Job Summary
Responsible for ensuring process validation according to procedures to support production and product release; ensuring that trends are analyzed; accountable for ensuring compliance to and enforcing regulations, standards, policies, SOP and instructions related to design control, engineering change management and risk management.
Job Responsibilities
Job Requirement
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