Senior Quality Engineer

Position Summary:
This position is responsible for Quality activities that measure,mon******** an******** Illumina’s compliance with the Quality SystemRegulat******** Illumina Quality pol******** cFDA/FDA regulationsan******** standards as well as Illumina product quality for currentoperation an******** objectives.

Tasks an****************
- Supports the distribution warehouse with focus on compliance withapplicable China GMP Quality Management System, Quality SystemRegulations (QSR), ISO 13485 requirements an******** Goo********Practice
- Ensures adequate control of nonconforming material.
- Manage ******** disposition an******** processes.
- Develop, review an******** Quality System documents (e.g.,Standar******** Proce******** Forms, Spec******** Val******** etc.) toensure compliance with applicable regulations (e.g., GMP, GDP, ********ISO, etc.)
- Monitor an******** key metrics an******** improvements to distributionprocesses.
- Facilitate the training program require******** distributionpersonnel.
- Ensure that records are complete, accurate an********.
- Support development an******** of process verification an********plans.
- Review an******** planne******** unplanne****************
- Collaborate with the Singapore Quality team to oversee, support,facilitate and/or drive the following area********
- Change management activities
- Compla******** recall, fiel********
- Compliance Au******** inspections
- Suppliers / Service providers management
- Quality Management Review
- Other such duties that may be determine******** Management.

All liste******** an******** are deeme******** essential functions tothis position; however, business conditions may require reasonableaccommodations for additional task an********.

All About You
Requiremen********
- Experience in Goo******** Practice (GDP)
- Experience in supporting logistic******** environment
- Experience in col******** an******** validation highly desired.
- Six Sigma/Lean training;
- Experience in CAPA an********;
- Project management certification
- Working for a Medical Device or Medical Diagnostics company;
- ISO 13485 an******** 9001 experience
- China FDA regulatory experience

Competencie********
- Ability to apply experience in meeting requirement of ChinaGoo******** Practice an******** 13485 Standard.
- Experience in applying appropriate quality tools.
- Effective failure ******** technical report wr******** data m********tren********, statistical analysis.
- Intermediate to advance******** with words processing an********,chart******** graphing tools an******** tools.
- May have experience with electronic production life (PLM), enterpriseresource planning tools (SAP) an********.
- May have experience with statistical analysis packages, eg, JMP,minitab.
- Must be detaile********, well organize******** able to workindependently an******** teams.

Educational:
- Bachelor’s Degree in Engineering or Biological/Life Sciences
- More than 5 years of working experience in a regulate********environment

Illumina is an Equal Opportunity Employer.

For intereste********, please do the following:
1. Visit our Careers Page at ********
2. Click 'Search Careers' an******** 4014BR in the 'Auto re********'fiel******** procee******** the application.