Job Summary

The Senior Tester in DAL Management plays a critical role in ensuring the quality and reliability of software products by executing comprehensive testing processes. This position emphasizes the importance of adhering to quality standards and client requirements by meticulously reviewing, creating, and executing test cases, thereby contributing to the overall success of the organization’s software development initiatives. Project Name MedTech Project Code: I 180074 Function Manufacturing Quality Job / Role title Quality Controller (QC) Location Madurai (Plant / Shopfloor) Employment Type Full-time | Shift-based (as required) Minimum Educational Qualification Required Diploma Minimum Years of Experience Required 5 Years of work experience Responsibilities and authorities: • Performing the Implant manufacturing quality activities and ensure delivering the quality products as per the Specification • Performing the incoming inspection for received parts/tools. • Performing the In-process inspection during the assembly and providing line clearance for each stage in the Manufacturing records. • Review and approve the Device History Records (DHR) and Device Master Record (DMR) • Review and approve the DHR Product traceability records. • Calibration management for the Instruments and ensure the relevant equipment’s are calibrated as per plan. • Periodic review and update of Master list of Tools and Fixtures - Validation review and approval. • Periodic review and update of Master list of Test equipment’s – Calibration, AMC review and approval. Equipment history and Breakdown review and approval. Reviewing the Test Equipment's calibration certificates, Equipment's annual maintenance and preventive maintenance report, Installation reports, and Tools & fixtures validation reports used for our Manufacturing process. • Request for the creation of Unique ID for Tools, Fixtures and Equipment’s. • Preparation of assembly work instruction. • Preparation of manufacturing documents like, process flow diagram (PFD), product process performance chart (PPPC), process failure mode and effects analysis (PFMEA), control plan (CP), Standard operating procedure (SOP), guidelines, floor layouts, technical specifications • Preparation of manufacturing records like templates, and monitoring sheets. • Conducting Design of Experiments for the new process and change in the process. • Review and handling the packaging and sterilization activities. • Participating in ISO 13485 Internal and External Audits. • Review and approval of IQ,OQ and PQ during the new equipment installation with the Manufacturer and service providers • Handling in-process quality checks for plastic components to ensure compliance with specifications. • Performing defect analysis, identifying root causes, and implementing corrective and preventive actions. • Preparing inspection reports and maintaining quality documentation. • Coordinating with production and tool room teams to address quality issues in real time. • Conducting operator awareness training and workstation audits. • Monitoring rejection trends, SPC p

Key Responsibilities

1. Create And Review Test Cases Based On Functional Specifications And Software Requirement Specification Documents, Ensuring Thorough Understanding And Coverage Of Testing Scenarios.
2. Execute Functionality Testing According To The Test Plan And Respective Test Cases, Validating Software Performance Across Various Environments.
3. Collaborate In The Development Of Test Plans By Contributing Insights And Experiences To Align Testing Strategies With Project Objectives.
4. Track Test Coverage, Defect Density, And Other Relevant Metrics Using Test Management Tools, And Publish Progress Reports To Stakeholders To Ensure Transparency And Alignment.
5. Coordinate With Team Members For Discussions And Updates, And Interact With Clients To Communicate Testing Progress And Address Any Concerns.

Skill Requirements

1. Strong Understanding Of Dal Management Principles And Practices.
2. Proficiency In Creating And Reviewing Test Cases And Test Plans.
3. Experience With Various Testing Methodologies And Tools.
4. Good Analytical Skills To Track And Report Testing Metrics.
5. Familiarity With Defect Tracking Tools And Reporting Processes.

Other Requirements

1. Istqb Foundation Level Certification Is Recommended, But Not Mandatory.
2. Additional Certifications In Software Testing Methodologies Are Considered Valuable.

Mandatory Skill:

Ø Good working Knowledge in medical quality management system ISO 13485.

Ø Good working knowledge in ISO standards - ISO14971.

Ø Good working knowledge in manufacturing quality process.

Ø Good working knowledge in manufacturing process.

 

 

Desirable Skill:

<Provide the desirable technical skills>

 

 

Tools: Mandatory Skill: Ø MS Office Desirable Skill: Ø MPP, ERP-SAP and QMS

Process:

Mandatory Skill:

Ø Good knowledge in calibration

Ø Internal Audit

Ø Production Process Quality Control

Ø Quality Management

Desirable Skill:

Ø Conflict Management

 

Communication Skills:

Mandatory Skill:

Ø Good team building skills

Ø Strong oral and written communication skills

Desirable Skill:

Able to communicate with cross functional team