Overview: The Sr. Quality Assurance Engineer shall provide leadership and support for QMS performance in many facets of business operations: **_

- Design Control_**

Risk Management

**_

- Material Review Board_**

The Sr. Quality Assurance Engineer shall facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders. Process performance metrics shall be captured, monitored, and reported to ensure timely and effective MRB throughput and minimized quarantine back log.

**_

- Installation and Service_**

The Sr. Quality Assurance Engineer shall ensure that post-market activities ensure intended device performance. Service and support activities must be adequately documented, attention escalated to facilitate defect handling, and product performance and performance trends assessed to understand and drive improvement opportunities

QMS Administration

In addition, the Senior Quality Assurance Engineer will support key Quality Management System (QMS) administration activities related to design and development. This includes conducting internal quality audits to verify compliance with internal procedures and global regulatory expectations, as well as leading or supporting Corrective and Preventive Actions (CAPA), including verifying effectiveness and ensuring all remediation activities are properly documented. The role will manage Process Change Control for design‑related processes, ensuring changes are appropriately evaluated, documented, reviewed, and approved. The Senior QA Engineer will also support external audits and inspections by providing documentation, explaining processes, and representing relevant quality activities.



Further responsibilities include assisting functional teams in understanding their quality obligations and maintaining alignment with the Spacelabs Quality Policy, as well as maintaining and improving QMS procedures, work instructions, and templates to ensure practices remain risk‑based, productive, and compliant.

Responsibilities : The Sr. Quality Assurance Engineer shall follow the guidance of RA/QA Management and help other organizational functions understand and fulfill their obligations to meet quality objectives, systemic responsibilities, and customer requirements, as defined by Executive Management in the Spacelabs Quality Policy. As part of maintenance of the Spacelabs Quality Management System, Senior Quality Assurance Engineers shall partake in some or all of the following responsibilities:

- Ensure high quality of products and services, by implementing and maintaining the Quality Management System.
- Ensure that QMS activities are risk-based.
- Perform, report, and drive remediation from Internal Quality Audits and participate in third party audit and inspection activities (MDR, MDSAP, etc.).
- Routinely pursue more efficient and effective operations (continual improvement).
- Support the development teams of all business areas, working within the project teams on new or sustaining product development projects.
- Support the maintenance of the Essential Requirements Checklists / General Safety, Essential Requirements checklist and Technical Documentation Files.
- Assist with the compliance to changes to standards such as EN 60601-1, ROHS3, REACH,



and Global regulatory requirements applicable to Spacelabs’ products.
- Provide Quality System guidance to his or her product design teams. He or she shall be well versed in all aspects of Design Controls, Risk Management, Electrical Safety and all associated processes, policies, procedures, and records.
- Collaborate with engineering to determine and execute engineering design and development planning in support of regulatory submissions.
- Review Engineering Change Requests and Engineering Change Orders to identify critical components, defects in drawings/schematics, effective and adequate design documentation, product safety, and Quality System compliance.
- Assist with the creation, maintenance, and performance of QMS change management tools: Corrective Action Reports (CAR’s), Preventive Action Reports (PAR’s), and Process Change Orders (PCO’s).
- Support the manufacturing teams of all business areas, working within the teams on new or sustaining product and process improvements.
- Shall review and approve Device History Record (DHR) deliverables to ensure that production activities comply with Mandatory Device Master Record (DMR) requirements.
- Perform Manufacturing floor walkthroughs based on 7S criteria to support improvements and collaboration.
- Facilitate efficient and effective processing of Nonconforming Material Reports and Rework Orders.
- Create and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP.
- Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
- Demonstrate behavior consistent with the company’s Code of Ethics and Conduct.
- It is the responsibility of every employ

📌 Senior Quality Assurance Engineer (Madhapur)
🏢 Celabs
📍 Madhapur