Quality Engineer

4 days ago


Ho Chi Minh City, Vietnam PERSOLKELLY Vietnam Full time

Medical Device
- Supplier Quality Engineer/Internal Audit experience
- Working location: Office in D3 & travel

**CORE JOB RESPONSIBILITIES**:

- Complete vendor quality system audits against e.g. ISO 13485:2016 and 21 CFR 820 for Medline Asia per SOP requirement including preparation, audit, reporting and follow‐up within a timely manner; lead key vendor coaching projects to help vendor establish, maintain and improve its quality system when necessary;
- Lead vendors to handle the 3rd party commodity, device GMP audits to avoid any adverse effect on supply chain stability;
- Training for vendors about Medical device manufacturing requirements (Validation, GMP, GDP, DMR, DHR, Bioburden, Changes control, Risk assessment analyst etc.)
- Project leader to do quality system improvement for local vendors
- Participate in FDA preparation projects to help vendors in FDA inspections
- Train cross‐functional employees: against quality system regulations and standards e.g. ISO 13485: 2016 and 21 CFR 820; to conduct quality system audits according to SOP requirement;
- Work closely with main stakeholders: to participate in vendor qualification process; to address quality issues in maintenance of current vendors;
- Other works assigned by supervisor.

**BASIC QUALIFICATIONS**

**Education and Experiences**:

- Bachelor’s degree in Engineering, Microbiology, Pharmacy or equivalent education;
- At least 2 year experiences as internal quality auditor in medical device manufacturing. Have experiences as vendor auditor is plus.
- To be in charged in ISO 13485, FDI/ GMP requirements

**Knowledge, Skill & Abilities Required**:

- Ability and willing of communication, problem solving, organizational skills;
- Good time and priority management ability to ensure efficiency of work;
- PC skills: MS Office Software;
- Good oral and writing English;
- Can accept a generally 50% travel rate

565993


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