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Sr Quality Engineer
4 weeks ago
Sr Quality Engineer The Sr Quality Engineer is responsible for ensuring the quality and safety of our genomic products and services by implementing and maintaining a quality management system (QMS) that complies with ISO 13485 and ISO 14971. This position is also responsible for conducting risk assessments, developing, and implementing corrective actions, and providing technical support to the R&D team. What You'll Be Doing Implement and maintain a QMS that complies with ISO 13485 and ISO 14971. Conduct risk assessments to identify and assess potential hazards associated with genomic products and services. Develop and implement corrective actions to address identified hazards and prevent recurrence of non-conformities. Provide technical support to the R&D team on quality matters, including design control, process validation, and change control. Conduct audits and inspections to verify compliance with QMS procedures and regulatory requirements. Prepare and maintain quality documentation, including risk management reports, corrective action plans, and audit reports. Stay up-to-date on relevant quality standards and regulations, such as ISO 13485, ISO 14971, and the FDA's Quality System Regulation (QSR). Lead internal CAPAs related to Supplier Controls. Lead high visibility complaints and Key customer incidents (Evaluations and Re-Evaluations). Support Internal and External Audits (FDA, EUIVDR, ISO, Customer, etc.) representing Supplier Quality in Audits Front rooms. Coordinate and participate in Internal Audits in addition to Supplier Audits. Ensure the Quality Systems group is appropriately staffed to ensure timely completion of responsibilities. What You'll Bring to the Team Bachelor's degree in Engineering, Quality Assurance, or a related field. 5+ years of experience in complaint handling, preferably in a genomics or medical device environment. Stay up-to-date on relevant quality standards and regulations, such as ISO 13485, ISO 14971, and the FDA's Quality System Regulation (QSR). Strong understanding of quality principles and practices, including ISO 13485 and Six Sigma methodologies. Experience in root cause analysis and corrective action implementation. Excellent communication and interpersonal skills, with the ability to interact effectively with customers, technical team members, and management. Knowledge of good manufacturing processes. Experience leading and mentoring team members. Experience making trade-off decisions while balancing compliance and business impact. Experience working in cross functional teams. Experience implementing practical Quality System and Compliance solutions. The base cash compensation for this California-based role is below. In addition to base salary, this role is eligible for bonus, equity, and a generous benefits package. Final compensation amounts are determined by multiple factors, including candidate skill, experience, expertise, and location and may vary from the amount listed above. Compensation may be different in other locations. San Francisco Bay Area Pay Range: $92,000 - $110,000 USD
