Quality Professional

Job Summary

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.

Responsibilities

• 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.

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