Quality Engineer – PL9
Mandatory Expectations
- In this position, you are responsible for following the Document control process
Additional Expectations
- In this position, you are also responsible for
Competencies
- Practical knowledge of Good Documentation Practices (GDP) and SAP for upload, download and document control work.
- 14971, MDD, MDR, 510(k) etc.)
- Knowledge on Software Development Life Cycle and Process Lifecycle Management.
- Ensuring compliance of products as per MI PLM and SHPL QMS requirements
· Co-ordination with Quality Manager on various SHPL QMS related activities
· Conducting/participating in Internal Audits and External Audits,
· Coordination and ensuring closure of audit findings within the projects.
Process Management
- Supporting for maintaining and improving of product and process quality
- Skills to Collaborate with all stakeholders to implement lean /agile initiatives across organization
- Quantitative Project Management using statistical methods
Desired Qualification and Experience
Qualification : BE / B.Tech/ MCA
Experience: 4 to 6 years’ experience in Quality Assurance & Document control.