Quality Systems

Role Objective:A key objective of this position is to design, implement and enhance organizational work practices that align with quality management principles. Role will focus on establishing a culture of continuous improvement, compliance and operational excellence within the organization. Role involves the development and maintenance of a Quality Management System (QMS), managing training initiatives and driving projects related to quality and regulatory compliance within the medical device sector.Desired Candidate Profile:Detail-oriented professional with 15 to 18 years of experience in Quality Assurance or related fields, preferably within the Medical Device Industry.Strong understanding of regulatory requirements, including FDA, ISO 13485, GMP and GDP.Proven expertise in developing and implementing QMS processes, handling compliance, and conducting internal audits.Demonstrated ability to lead quality-based projects and manage cross-functional teams.Excellent communication and leadership skills, with a track record of successful project management and stakeholder engagement.Responsibilities:Quality Management System (QMS) Development:Design, implement, and maintain a robust QMS framework in line with regulatory requirements and industry standards.Authorize and review SOPs, master documents, and quality protocols, ensuring comprehensive compliance across all operational processes.Compliance & Documentation:Oversee the approval process for Site Master Files, Validation Master Plans, Quality Manuals, and stability summary reports.Ensure procedural compliance in handling Change Control Notices (CCN), deviations, market complaints, Out-of-Specification (OOS) issues, CAPA, and IPQA non-conformances.Conduct document reviews for new product launches, ensuring alignment with regulatory requirements.Audit & Risk Management:Lead internal audits and self-inspections to assess compliance with quality standards and identify areas for improvement.Investigate quality-related issues, conduct root cause analysis, and implement corrective and preventive actions (CAPA).Project Leadership:Drive quality improvement projects and initiatives, collaborating with multidisciplinary teams to enhance operational efficiency and compliance.Act as the Management Representative (MR) for quality reviews, planning and conducting Management Review Meetings (MRM), and following up on action items.Business Continuity & Process Improvement:Support the business continuity management plan, ensuring seamless operations during disruptions.Continuously monitor and improve QMS activities, including change control, deviation management, and CAPA implementation.Training & Development:Identify training needs across departments and design comprehensive training programs on GMP, QMS, and regulatory compliance.Implement and manage online training systems, ensuring consistent knowledge dissemination and compliance awareness among staff.Functional Skills Required:Strong expertise in Quality Assurance, QMS implementation, and regulatory compliance.Proficiency in managing quality projects, conducting internal audits, and performing gap analyses.In-depth understanding of GMP, GDP, ISO 13485, and FDA regulations.Ability to lead and manage cross-functional teams effectively.Competence in conducting training programs and implementing quality improvement initiatives.Behavioral Skills Required:Leadership and Team Management: Ability to guide, motivate, and develop team members towards achieving organizational goals.Attention to Detail: High level of precision in reviewing documents, managing audits, and ensuring compliance.Problem-Solving & Analytical Thinking: Strong capability to identify issues, analyze root causes, and implement effective solutions.Communication & Interpersonal Skills: Excellent communication skills, with the ability to interact effectively with stakeholders at various levels.Adaptability & Change Management: Ability to adapt to changing business needs and lead initiatives for continuous improvement.Team Size to be Handle:Manage a team size of over 12 to 15 QA professionals, reporting directly to the Vice President of Corporate Quality.A minimum of 4 to 5 years of Medical Device QA experience will be advantageous.Important Links:Website: https://biotechhealthcare.Com/LinkedIn: https://www.Linkedin.Com/company/biotechhealthcare/Instagram: Biotech Vision CareBiotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.