Quality Assurance Engineer Job in Noida at Saraca Solutions Pvt. Ltd.

Saraca Solutions is hiring for the position of Quality Assurance Engineer!

Responsibilities of the Candidate:

• Support the Quality Management Systems compliance with the appropriate internal & external regulatory requirements
• Contribute in developing optimum future state of QMS for business needs, aligned with Corporate, Divisional & GQO QMS requirements
• Assess & Quantify requirements for support of QMS to optimum structure under which the service required will be provided
• Drive GMP and GDP practices within Quality
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the Quality Management Systems.
• Develop & deliver training/compliance for QMS group.
• Contribute to the development, maintenance and improvements of the policies, procedures processes and systems
• Implement best in class QMS practices and benchmark against industry leads and regulatory requirements
• Ensure QMS reflects actual activities and business needs, and supports NPI requirements
• In a project environment, contribute to the development and/or modification of Stryker's regional/local Quality Management Systems
• Proficiently take part in information systems discussions as required. Thinks about QMS from an IT perspective, including proficient contributions to SRS/URS activity
• Understands Quality Systems & web-based interactions
• Proficiency in executing and leading projects, understands project stages
• Proficient in improvement methods and processes
• Key contributor to the business process(es) and understands how IT system supports those business processes
• Supports the business during audits to discuss system functionality

Requirements:

• Bachelor’s degree or equivalent in Engineering, Quality or related subject required
• Minimum of 4 years in Quality/Technical environment with 2 year’s experience in a role exposed to Quality Management Systems (Medical experience would be preferred)
• Experience working with QMS systems implementation required
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired
• Thorough knowledge and understanding of US and International Medical Device Regulations
• Strong knowledge of Quality or ERP Systems (e.?g.? Data, NC/CA?PA, IT deployment etc.)
• Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously
• Demonstrated ability to successfully manage and complete projects in a matrix organization
• Demonstrated ability to work independently
• Experience in working in a compliance risk situation