Senior Quality Engineer

Year    Thane, Maharashtra, India

Job Description


Revvity is an international developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world\'s greatest health challenges. We have deep experience in our field, having been part of Revvity\'s 85-year history, and are excited for our future as a dedicated life sciences & diagnostics business. Our diverse team of 11,000+ colleagues from around the globe are vital to our success and the reason we\'re able to push boundaries in pursuit of better human health. Find your future at Revvity! We are looking for Quality Engineer to strengthen our Europe Commercial Quality team, supporting Revvity Distribution and Service activities in different European locations. Form of this role is hybrid/remote. Responsibilities: Work with commercial teams in different European locations to ensure implementation and/or maintenance of QMS that are appropriate for Medical Devices / Medical Devices Distribution and Services, ISO9001, IVDR and other applicable regulatory and statutory requirements. Coordinate, plan and manage audits (internal/cross-sites). Facilitate external audit by certification body and support regulatory inspections by regulatory agencies Perform internal audits of processes, facilities and documentation to assure compliance with internal procedures and regulatory requirements. Establish, maintain and update relevant QMS documentation. Coordinate the Quality Management Review meeting on scheduled basis and prepares metrics and reports. LMS administrative role for local procedure and practice. Conduct customer feedback/complaints and trend review, and drive appropriate continual improvement implementation. Support all Quality compliance and regulatory activities. Requirements: Bachelor\'s Degree in science or engineering or quality fields Fluent English, both spoken and written. At least 3 years of experience in quality engineering, preferably in life sciences, pharmaceutical or healthcare industry. Knowledge of Quality Management Systems (QMS) standards, including ISO9001, IVDR, and other applicable regulatory and statutory requirements. Excellent problem-solving skills and attention to detail. Excellent communication and interpersonal skills. Ability to build strong relationships and engage internal stakeholders in QMS ownership, sensitive to working in a complex multinational environment. Proficiency in Microsoft Office - advanced level. Experience of ERP and CRM is advantageous.

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Job Detail

  • Job Id
    JD3178482
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Thane, Maharashtra, India
  • Education
    Not mentioned
  • Experience
    Year