Quality System Engineer

Job Description

Job TitleQuality System EngineerLocation(s)MumbaiSummarySeeking an experienced engineering professional who works well in a cross-functional team environment. The individual will support our efforts to attain and maintain Quality Management System compliance, as well as ensuring that we comply with applicable regulatory and statutory requirements. Must be able to work independently and resolve Quality Systems and regulatory compliance and quality program related issues in a creative, high quality, timely and cost-effective manner. Core values must include commitment to customer excellence with demonstrated ethics and integrity.Responsibilities:

• Oversee generation, approval, and compliance management of applicable QSR documentation.
• Audit/create/review/approve/release production Quality System documents/SOPs/work instructions as required, ECOs and Batch Records during device manufacturing, and communicate necessary changes to applicable department representatives to maintain compliance.
• Participate in internal & external audits of applicable QSR/ISO processes to meet regulatory requirements for the site. Support Quality Team by addressing audit findings, implementing CAPA, and updating Quality System documentation as needed.
• Independently communicate within the project teams as well as Sr. Leadership through project reviews, status reports, Quality System metrics, and data reporting for Management Review. Present quality metrics in Management Review.
• Communicate effectively within the project teams as well as Sr. Leadership through project reviews and status reports. Prepare special reports for Manufacturing, Operation, Development, Suppliers and others as necessary. Facilitate meaningful and constructive exchange of ideas and knowledge;
• Perform/supervise internal & external audits of applicable QSR/ISO processes and maintenance of applicable QSR databases to meet regulatory information tracking needs.
• Perform/supervise investigations into product incident reports of internal (R&D, receiving, production, shipping) & external (customer complaints, service reports) adverse events, with emphasis on use of root cause and/or other analysis tools and verify effectiveness of implemented corrective actions to prevent recurrence of adverse events.
• Provide support in general quality program issues to support Quality Department effectiveness.

• Requires a BS (MS a plus) in Engineering and/or technical discipline, or equivalent, with minimum of 2-5 years related experience and/or training; or equivalent combination of education and experience

• Experience with scientific instrumentation in a design and manufacturing environment; in either a quality, regulatory, design, or manufacturing role; within a medical device related company; or equivalent
• Quality auditor, regulatory investigator, or equivalent status, and/or also with having performed internal process audits
• Problem root cause analysis, verification & validation, flow mapping, and organizational and time-management skills
• Computer proficiency with background in Agile and SAP business information systems a plus
• Working knowledge of Medical Device Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD)
• Working knowledge of MDR, IVDR. Specifically, Labeling requirements (UDI and MEDDV)
• Must utilize lessons learned to improve effectiveness of project teams you will be working with, including aptitude to learn new systems and retain technical information
• Energetic, results-driven with excellent organizational and prioritization skills
• Excellent written and verbal communication skills and highly effective time management skills
• Ability to operate independently and as part of a team
• Commitment to continuous improvement principles

Keyskills :
root cause analysisinspectionisocontinuous improvement facilitationiso 13485project teamscncquality management systemroot causeppapcomplianceexternal auditiso 14971data reportingbatch records