Senior Quality Professional

2 weeks ago

Goa, India beBeeQualityAssuranceManager Full time ₹ 20,00,000 - ₹ 25,00,000

Job Opportunity

The role of Quality Assurance Manager is responsible for establishing, maintaining and continually improving the Quality Management System (QMS) across the full lifecycle of In Vitro Diagnostic products in accordance with regulatory requirements.

This position provides QA oversight across manufacturing and post-market activities, ensures regulatory compliance, drives continuous improvement initiatives and fosters a strong quality culture.

Key Responsibilities:

  • Oversight of document and record control, deviations, change control, incidents, out-of-specification results and quality risk management processes.
  • Leadership of Nonconformance and Corrective Action Preventive Action (CAPA) processes including root cause analysis, implementation of corrective/preventive actions and reporting CAPA trends to the Quality Head.
  • Planning, monitoring and support of internal and external audits; confident management of regulatory inspections.
  • Identification, design and implementation of training programs for Quality Assurance and cross-functional teams to promote a quality and compliance culture.
  • Drive continuous improvement through proactive risk management and cross-functional collaboration.

Required Skills & Qualifications:

  • Deep understanding of In Vitro Diagnostic / Molecular Biology products.
  • In-depth knowledge of ISO 13485:2016 and ISO 14971 (Risk Management).
  • Proven ability to lead audits and regulatory inspections successfully.
  • Strong leadership, interpersonal and team management skills.
  • Excellent collaboration and stakeholder management abilities.
  • Proactive and solution-oriented mindset with a strong focus on quality culture.
  • High attention to detail and risk-based thinking.

Skillful Attributes:

  • Verbal and written communication skills.
  • Able to simplify and effectively communicate complex regulatory/quality requirements to diverse stakeholders.

Behavioral Characteristics:

  • Integrity and professionalism.
  • Analytical and problem-solving abilities.
  • Customer-focused and committed to compliance excellence.
  • Demonstrates a continuous improvement mindset.
  • Adaptable to a dynamic regulatory environment.

Work Experience:

  • At least 12 years of experience in the In Vitro Diagnostic industry with at least 3 to 5 years in a leadership/managerial role.
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