Quality Engineer

This is a remote position.

We are seeking a talented and self-driven Quality Engineer to ensure all products, processes, and quality systems within the organization comply with applicable medical device regulations and global standards. This role is integral to driving quality excellence across the product lifecycle from design and development through manufacturing, validation, and post-market [link removed] ideal candidate possesses a strong technical foundation, meticulous attention to detail, and a proactive approach to problem-solving and continuous improvement. This individual will collaborate cross-functionally with R&D, Manufacturing, Regulatory, and Supplier Quality teams to uphold the highest levels of product safety, compliance, and [link removed] ResponsibilitiesSupport design control activities, ensuring design inputs, outputs, verification, and validation meet regulatory and organizational [link removed] in risk management activities (ISO 14971), including FMEA and hazard [link removed] and maintain Design History Files (DHF), technical documentation, and change control [link removed] with R&D, Manufacturing, and Regulatory teams to ensure compliant design transfer into [link removed] and lead process validation activities (IQ/OQ/PQ), ensuring adherence to validation master [link removed] nonconformances and conduct root cause investigations using structured problem-solving tools (5 Whys, Fishbone, etc.).Drive Corrective and Preventive Actions (CAPA) to timely closure and verify [link removed] production processes and quality metrics, identifying trends and improvement [link removed] equipment qualification, calibration, and validation maintenance to ensure [link removed] in supplier qualification, performance monitoring, and audits to verify compliance with quality [link removed] Supplier Corrective Action Requests (SCARs) and collaborate with suppliers to resolve quality [link removed] incoming inspection results, PPAP documentation, and supplier process [link removed] and continuously improve the Quality Management System (QMS) in compliance with 21 CFR Part 820, ISO 13485, MDSAP, and EU [link removed] for and support internal, external, and regulatory audits, including documentation and response [link removed], revise, and implement Standard Operating Procedures (SOPs) and work [link removed] in change control reviews to ensure ongoing product and process [link removed] data analysis and statistical tools (SPC, Cpk, Minitab, etc.) to drive process and product [link removed] Lean Six Sigma methodologies to enhance efficiency and reduce [link removed] to cross-functional projects focused on risk mitigation and operational [link removed] training and mentoring of cross-functional teams on quality principles, tools, and regulatory [link removed]-Have QualificationsBachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related scientific [link removed] in a regulated medical device environment with working knowledge of FDA QSR, ISO 13485, and ISO [link removed]-on experience in process validation, CAPA, risk management, nonconformance investigations, and audit [link removed] with statistical analysis tools and data-driven quality [link removed] communication, documentation, and cross-functional collaboration [link removed] in Lean Six Sigma, ASQ CQE, or a similar credential [link removed] QualificationsWorking knowledge of MDSAP, EU MDR, and other international regulatory [link removed] with electronic QMS platforms (e.g., MasterControl, TrackWise, Veeva).Experience with combination products, sterilization validation, or cleanroom manufacturing [link removed] is intended for inclusion in Pharmavise’s talent database to build a qualified pool of professionals for future medical device client requisitions.

Originally posted on Himalayas