Kind of contract
Provide technical analysis of processes that are involved in the development and manufacturing of products in order to ensure that they are in compliance with quality requirements and meet specifications. Help and support such activities while ensuring that applicable standards and procedures are followed.
Participate in Project teams and representing Quality groups and ensuring that Design Control requirements are met. Support Corrective and Preventive actions
- Ensure that appropriate procedures are established to support Design Development processes.
- Review of design and development processes and ensure that appropriate documentations are established during this process in accordance with the Design Control procedures. ·
- Review verification and validation activities to ensure that they are well established and compliant with the regulations.
- Review specifications, operation instructions, process procedures, test procedures, inspection and test analysis.
- Support in providing leadership in the application of Quality Tools such as Risk Management, Root Cause Investigations, and investigation of process and products failures and implement lasting solutions of such failures.
- Support the risk management activities for new product development including risk plans, and reports and assisting with all FMEAs to ensure compliance.
- Develop process flow diagrams and perform gap analyses on current controls/status versus required controls/status.
- Assist in corrective and preventive actions and verifications of effectiveness checks for internal and external audits.
Qualifications Experience Personal Strengths Mobility
2 to 3 years related experience in IVD, medical, pharmaceutical, or other related industry in Quality department
- Must have a thorough understanding of statistical quality control, statistical process control, Corrective Action Process, and their application manufacturing as a problem identification and resolution tool.
- Proficient in Advanced SPC, Quality Analysis Tools (Taguchi, Fishbone) & DOE. ·
- FDA Process Validation Techniques preferred
- Software product development experience within the IVD environment a plus
- Good interpersonal skills, professionalism.
- Ability to work with cross -functional teams
- Time management skills and organization skills; analytical skills; Problem-solving
- Group work orientation.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Induction Program Once Hired
As for Company Policy