Process Validation Engineer
Job Title: APQP Engineer
Location: Andover ,MA
1.6-8 years of Quality engineering experience.
2. Quality Engineering experience in Medical Devices (at least in Class I & II) at least 3 years.
3. Full Quality System Knowledge.
4. Extensive Gage R&R experience.
5. Process FMEA.
6. Process Control Plan
7. Measurement System Analysis Studies (Gauge R&R).
8. Process Capability Analysis (Cpk).
9. Process Qualification (e.g. IQ, OQ, PQ).
10.First Article Inspection (FAI).
11.First Production Inspection (FPI).
12.Critical to Quality (CTQ).
13.Supplier Corrective Action Request (SCAR).
14.Incoming inspection Plan.
16. 21 CFR 820
17. ISO 13485
'Quality Engineering, Quality Compliance and Project Management
'1. Must possess strong Critical Thinking capabilities that can identify the best quality system/method solutions.
2. Needs to anticipate Philips customer needs for each assigned project, and reject any excessive requirements.
3. Needs to be very comfortable with the amount of customer interface as it will be significant and extensive.