Process Validation Engineer

  •  

Andover, MA

Industry: Engineering Services

  •  

5 - 7 years

Posted 290 days ago

  by    Bajrang Yadav

This job is no longer available.

Job Title: APQP Engineer

Location: Andover ,MA

 

Overview:

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.

15.Remediation Planning.

16. 21 CFR 820

17. ISO 13485

 

Primary Skills:

'Quality Engineering, Quality Compliance and Project Management

 

Secondary Skills:

'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.

 

Educational Qualifications

Mechanical Engineering