Senior Quality Systems Engineer

Found in: Talent MY C2 - 2 weeks ago

Simpang Ampat, Malaysia Haemonetics Full time

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

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.

Job Requirement

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

EEO Policy Statement

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