QMS

QMS_Chakkaravarthy Hyderabad · Full-time · Hybrid

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About the Role This role involves supporting QMS assessment and implementation, conducting gap analyses, and documenting QMS processes. The successful candidate will work under the guidance of Senior BAs and QA leadership to ensure compliance with regulatory requirements. The role is critical in ensuring the quality and compliance of medical devices.

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Key Responsibilities

• Conduct gap analyses of current QMS processes against ISO 13485, 21 CFR Part 820, and EU MDR requirements
• Support documentation of QMS processes, SOPs, work instructions, forms, and quality records across design, manufacturing, and post-market phases

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Requirements

• Develop and maintain QMS processes and documentation
• Analyze and implement QMS requirements for regulated medical devices
• Collaborate with cross-functional teams to ensure QMS compliance
• Manage and maintain quality records and documentation
• Ensure compliance with regulatory requirements and standards

However, the original JD does not explicitly mention the above key responsibilities and requirements in the "Key Responsibilities" and "Requirements" sections. Therefore, the correct output should be:

QMS_Chakkaravarthy Hyderabad · Full-time · Hybrid

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About the Role This role involves supporting QMS assessment and implementation, conducting gap analyses, and documenting QMS processes. The successful candidate will work under the guidance of Senior BAs and QA leadership to ensure compliance with regulatory requirements. The role is critical in ensuring the quality and compliance of medical devices.

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Key Responsibilities

• Conduct gap analyses of current QMS processes against ISO 13485, 21 CFR Part 820, and EU MDR requirements
• Support documentation of QMS processes, SOPs, work instructions, forms, and quality records across design, manufacturing, and post-market phases

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Requirements

• Have 8+ years of experience in Business Analysis, Quality Assurance, or Regulatory Affairs within the medical device industry
• Have minimum 5 years of direct involvement in QMS implementation, documentation, or compliance activities for regulated medical devices
• Have experience working on Class II or Class III medical device programs in FDA and/or EU regulatory environments
• Have exposure to SaMD (Software as a Medical Device) or connected device programs
• Have working knowledge of ISO 13485 2016
• Be familiar with 21 CFR Part 820
• Have basic to intermediate understanding of EU MDR 2017/745
• Have exposure to IEC 62304
• Have awareness of IEC 82304-1
• Be familiar with IEC 62366-1
• Have understanding of ISO 14971 2019 / ISO 24971 2020

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Good to Have

• Have CCBA or CBAP (Certification in Business Analysis / Certified Business Analysis Professional)
• Have RAPS RAC (Regulatory Affairs Certification)
• Be an ISO 13485 Internal Auditor or Lead Auditor
• Have ASQ CQPA or CQE (Quality Process Analyst / Quality Engineer)