Senior Product Quality Engineer

Overview

Senior Product Quality Engineer providing design quality engineering guidance and support for New Product Introduction (NPI) and Product Life Cycle Management (LCM) activities, with a focus on product quality and compliance with the company-wide Quality Management System and regulatory requirements for life science products.

What you'll do

• Own the Risk Management process and deliverables (hazard analysis, DFMEA/SWFMEA, software hazard analysis, risk control verification, and the Risk Management File/Report per ISO 14971), collaborating with functional areas to facilitate risk analyses and design control processes, and review and approve design verification and validation documentation.
• Own the complaint-to-design-input pathway as the Design Quality liaison between Customer Quality and Design Engineering, assessing field signals against the risk file, translating them into design inputs, and tracking implementation and verification of effectiveness.
• Perform complex technical investigations, including formal NCs and CAPAs, coordinating cross-functionally to ensure sound experimental design, appropriate risk analysis, design control, and timely investigation closure.
• Act as a resource for colleagues in risk management, design control, verification and validation, or CAPA, and support new product introduction, design changes, and post-launch activities.
• Provide training and informal guidance on quality management system elements to less experienced colleagues and representatives from other functional areas.
• Identify and recommend improvements to quality systems, products, and processes in alignment with quality and business objectives, applying tools such as 6-Sigma, Lean, and statistical methodologies.
• Support and participate in cross-functional projects and lead small projects with manageable risks and resource requirements.
• Participate in technical reviews, explain difficult or sensitive quality information, and build cross-functional consensus.
• Ensure quality control plans are commensurate with product risk and consistently followed across own and related teams.
• Communicate business-related issues and opportunities to the next management level and recommend appropriate actions within the role's scope.
• Support internal, external, and third-party audits as Quality Subject Matter Expert and respond to observations; provide back-room support for third-party inspections and audits.
• Interface with contract laboratories or external design/development partners on behalf of the company to build consensus on technical and quality requirements.

What you'll need

• Bachelor's degree in engineering, Science (Biology, Microbiology, Chemistry, etc.) or other technical field.
• Minimum 3 years quality engineering experience in FDA or other regulated industry (medical device, pharmaceutical, aerospace, etc.) or equivalent.
• Experience planning and executing projects, including critical path analysis, and analytical, microbiological, or hardware/software test method validation.
• Outstanding business and technical communication skills (verbal, written, presentation).
• Ability to communicate in a cross-cultural environment.
• Proficient in Microsoft Excel, Word, PowerPoint and other standard software.
• Demonstrated proficiency in Risk Management, FMEAs, Design Control, Root Cause, and Design Verification and Validation methodologies.
• Strong working knowledge of FDA QSR 21 CFR 820 / ISO 13485 quality system requirements and knowledge of regulatory requirements and other compliance areas.
• Knowledge of Quality Engineering and Scientific methods (method development, method validation, method transfer), statistical analysis tools, and other techniques.
• Fundamental technical understanding of manufacturing equipment and processes.
• Ability to work independently with minimal guidance, prioritize and manage multiple activities, and build consensus across functions.

Nice to have

• Engineering degree.
• At least 5-8 years of experience in Quality Assurance, Quality Engineering, or related field.
• Medical device industry experience.
• Familiarity with requirements/test management and defect tracking tools (e.g. Jira/Xray/DOORS) and statistical and/or other data analysis software.
• Working knowledge of IEC 62304, ISO 14971, IEC 62366-1 and the IEC 60601 series.

Details

• Location: Bangalore, India.
• Working type: Hybrid.
• Reports to: Manager, Product Quality (India).
• Travel: Domestic up to 15%.
• Lifting requirement: Medium (16-30 lbs).
• Eligible for bonus as part of the total compensation package.