Quality Professional

ITH Icoserve; Bengaluru; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

ITH Icoserve is seeking a Quality Engineer to support the maintenance and improvement of the Quality Management System. You will review standards, manage QMS documents, and coordinate approvals and archiving with cross-functional teams in Bengaluru.

The role involves ensuring bilingual English/German document readiness and maintaining SAP-based workflows, while contributing to QMS tools and compliance activities across hardware and software domains.

Qualifications

• BE/B.Tech/MCA or equivalent quality qualification.
• Experience with ISO 9001/13485; EU MDR/FDA knowledge desirable.
• 5–10 years in Global (Hardware & Software) QMS experience.

Responsibilities

• Review standards and prepare structured review protocols.
• Perform delta and gap evaluations and document actions.
• Maintain regulatory and standards repositories.
• Prepare and format bilingual English/German QMS documents.
• Upload documents into SAP and manage reviews and signatures.
• Support change-management and tracking of document status.
• Coordinate with Quality, Regulatory Affairs and cross-functional stakeholders.
• Contribute to tools for QMS maintenance and audits.

Skills

QMS knowledge

Document control

Regulatory standards

Software QA

SAP document management

Microsoft Excel

Analytical ability

Written communication

Stakeholder coordination

Education

BE/B.Tech/MCA or equivalent

Tools

SAP document management

Microsoft Excel

Job description

Quality Engineer supports the maintenance and continual improvement of the Quality Management System by evaluating new and revised standards, preparing controlled quality documentation, coordinating document approvals, and ensuring that quality records are correctly released and archived.

Job Description:

• Review new or revised standards, regulations and QMS requirements and prepare structured review protocols.
• Perform delta and gap evaluations between existing and revised standards, identify affected QMS documents, and document required actions.
• Maintain regulatory and standards repositories, including addition of new standards and maintenance of associated references.
• Prepare, revise and format controlled QMS documents, including bilingual English and German documents.
• Conduct formal quality checks of procedures and templates, including verification of links, terminology, wording, references and document structure
• Upload documents and quality records into SAP and coordinate reviews, approvals and electronic signatures.
• Support QMS change-management activities and maintain tracking sheets for document status and signatures.
• Supplier Evaluation: Support preparation and signature coordination of quality-related accession or interface statements.
• Maintain controlled lists, including CCB and governance-related lists.
• Contribute to the creation and improvement of tools used for QMS maintenance, audit planning and document tracking.
• Support quality and regulatory stakeholders in implementing applicable QMS requirements

Qualifications and Experience

• BE, B.Tech, MCA, or a comparable technical or quality-related qualification.
• Experience in Quality Management Systems, document control, regulatory standards or software quality assurance.
• Working knowledge of ISO 9001 and ISO 13485; knowledge of EU MDR, FDA requirements or MDSAP is desirable.
• Experience with SAP document management, controlled-document workflows and Microsoft Excel is preferred.
• Strong analytical ability for standards comparison, gap assessment and formal document review.
• Strong written communication and attention to detail.
• Ability to coordinate with Quality, Regulatory Affairs and other cross-functional stakeholders.
• Experience: 5-10 years of experience in Global (Hardware & Software) Quality Management System.