Senior Engineer Industrialization

We are Hiring for Medical Devices Company

Profile- Engineer/Sr. Engineer Industrialization

Qualification: Diploma/B.Tech. Mechanical

Experience: 6-9 years

Skills requires: FMEA, PFMEA, DOE, NPD, Process validation, strong hold on documentation, IQ PQ OQ, good written communication in English.

Location: IMT Manesar

CTC: Up to 7 LPA

Skills:

1. Knowledge of Validation requirements (IOQ, OQ, PQ). Knowledge of Documents management system. Change Management (ECR / EC).
2. Quality Management System
3. Six Sigma
4. PPAP, APQP, PFMEA
5. Lean tool: RCA, CAPA, 8D, kaizen, Poka- Yoke, Ishikawa, DMAIC
6. GD&T
7. SAP: PP, MM Module (Material Master, BOM, Routing, Planning)
8. Computer basic -Microsoft Project Plan, Excel, Word, Outlook, Power Point.
9. ISO:13485-2016.

Primary Responsibility:

• Accountable for validation related activities (Draft, review, Execution, and report completion)
• To layout and review validation protocols for vascular products.
• Execution and validation protocol for Vascular process.
• To compile and review validation test reports in line with protocol. To draft and review validation reports.
• To provide validation related training to all concerned.
• To review work instruction, process documents of vascular products.
• To layout and review of equipment qualification protocols and repots.
• To participate and support with cross functional team for FMEA.
• QIP project drive with DMAIC methodology
• KPI Participation.
• To Provide Validation Related training to all concerned person.
• To report any deviation and conduct RCA.

Secondary Responsibility:

• To support DMD team for lean implementation
• PFMEA review
• To support Quality and production team for technical documentation.

Interested Candidates can share there CV at [email removed]

Regards

Nupur Tathe

(HR Recruiter)

Pace HR Consulting LLP

Contact No- [phone removed]