QMS implementation, maintenance & compliance: Ensure to drive day to day application of QMS processes and respective activities in compliance to implemented Global & Local QMS processes and applicable regulations & regulatory standards (Primarily in reference to MDR 2017, CDSCO / IPC, ISO-13485 & ISO-9001 standards) by assisting QARA management, leading team members and executing and / or monitoring assigned QARA tasks.
Quality Management System:
- Internal & External Audits: Organize and conduct internal QMS audits as per requisite frequency and process need.
- Training & Qualification: Assess competencies for QMS procedures. Monitor and facilitate QMS trainings at OMSI for timely completions.
- Document Control: Monitor Document, Change Control & Records at OMSI are in line to QMS requirements.
- NC & CAPA Management : Responsibleto assist management of Nonconformance & CAPA, including impact assessment, risk analysis, RCI (route cause investigation) and closure, for timely and effective actions as per relevant QMS process & timelines.
- Complaint Handling & Reportable Adverse Event Assessments: Monitor timely complaint assessments and responses to DD (Due Diligence) as per relevant QMS processes.
- Monitor & maintain Global & Regional KPI in line to requisite levels.
- Understanding Technical aspects of Olympus products to assess risk, impact and investigations for complaints, adverse events, non-conformities and CAPAs.Ensure to drive Supplier quality control, by establishing and monitoring supplier quality relevant tasks, such as supplier status, timely QAAs, audit results, quality compliance and performance evaluation
- FCA / Recalls & Ship Hold Control: Should be able to understand executions & monitor FCA / Recall & Ship Hold Relevant tasks (Timely FCA & Ship hold communications) for process compliances.
- Communication & Coordination Skills: Should be able to coordinate and interact with relevant QMS stake holders (internal & external), wherever applicable and assigned.
- Team coordination & leadership: Able to lead team for efficiently executing respective quality relevant tasks and smooth monitoring.
Qualification – B.Tech in Electronics, Bio-medical Engineering, Mechanical, Digital Electronics or Pharma Science
And Certified Internal Auditor or Lead Auditor on ISO-13485 from leading institute such as TUV / BSI or ASQ or other reputed academy.
Preferred Experience –
- Minimum 8 years of working experience with QMS / QARA process execution / management in an international organization dealing with Medical Device / Equipment with intensive experience on Internal Audits for ISO 13485 standard as Internal Auditor or Team Auditor or Lead Auditor.
- MS Office (focus Excel / Teams / Outlook), Agile, SFDC, Argus, etc.
- Fluent in oral/written communication (English)
- Business Acumen:- Ability to tap into one's knowledge of the business environment to further the organization's agenda
- Customer focus (Internal and External):- Focusing effort towards achieving Customer Delight in line with Olympus values
- Execution Excellence:- Ensuring seamless execution of organizational/ departmental strategy to achieve results as per Olympus quality standards
- Domain Expertise:- Applying one's knowledge and expertise for the benefit of the organization
- Communication:- Ability to effectively transmit one's message across to the recipient
- Developing Organizational Talent:- Fostering a culture of development within the organization to fulfill individual as well as organizational aspirations.
- Team Leadership:- Keeping a team motivated and engaged to work together towards organizational goals
