Quality Assurance Manager

We are currently seeking a talented Lead Software Quality Assurance Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management, risk management, verification and validation, navigating the cybersecurity guidance, as well as a deep understanding of the medical device industry.

Job Title: Manager QA.

Experience: 1015 years in Quality Assurance, with at least 5 years in a leadership or managerial role in the medical device industry.

Qualification:

• Bachelor’s or master’s degree in engineering, Life Sciences, Quality Management, or related field.
• Certifications such as Internal/Lead Auditor ISO 13485, CQA (Certified Quality Auditor)

Job Description:

We are seeking an experienced and dynamic QA Manager to lead our Quality Assurance team and ensure compliance with regulatory and quality standards in the design, development, and manufacturing of medical devices. The QA Manager will be responsible for implementing and maintaining an effective Quality Management System (QMS), driving continuous improvement, and supporting cross-functional teams to achieve high-quality products aligned with global regulatory requirements.

Responsibilities

• Develop, implement, and maintain the

  Quality Management System (QMS)

  in compliance with

  ISO 13485, FDA 21 CFR Part 820, MDR, and other applicable regulations

  .
• Lead internal and external audits, including FDA, ISO, notified body, and customer audits.
• Ensure effective

  CAPA, NCR, change control, and deviation management processes

  .
• Oversee document control, records management, and quality assurance reviews.
• Establish and monitor

  quality objectives, KPIs, and continuous improvement initiatives

  .
• Manage

  supplier quality audits, vendor qualifications, and incoming inspection processes

  .
• Collaborate with R&D, Regulatory, Manufacturing, and V&V teams to ensure compliance during

  product development lifecycle and design transfer

  .
• Train, mentor, and lead the QA team to strengthen organizational quality culture.
• Ensure effective risk management in accordance with

  ISO 14971

  .
• Drive initiatives for

  process validation, software validation, and equipment qualification

  .
• Provide management with regular updates on quality system performance and improvement opportunities.

Required Skills:

• Strong knowledge of ISO 13485, FDA QSR (21 CFR 820), EU MDR, and other applicable global regulations.
• Hands-on experience with audits (internal, external, regulatory, supplier).
• Proven expertise in CAPA, risk management, process validation, and complaint handling.
• Proficiency in quality tools (Root Cause Analysis, Six Sigma, FMEA, SPC, etc.).
• Excellent leadership, team management, and communication skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Proficiency in documentation, reporting, and use of electronic QMS tools.

Preferred Skills:

• Experience with SaMD (Software as a Medical Device) or IoT-enabled medical devices.
• Knowledge of ISO 27001, IEC 62304 (software), IEC 60601 (safety), and cybersecurity standards.
• Experience in working with global regulatory bodies (FDA, EU Notified Bodies, TGA, PMDA, etc.).
• Lean Six Sigma Green Belt/Black Belt certification.
• Prior experience in supporting regulatory submissions and technical documentation (Design Dossier/Technical File).

Location:
Thane (West), Mumbai