Quality Engineer - Complaint Handling

  Quality Engineer – Customer Quality Experience The Quality Engineer - Complaint Handling plays a critical role in ensuring the quality and safety of our genomic products and services. This position is responsible for identifying, investigating, and resolving customer complaints in a timely and efficient manner. The ideal candidate will have a strong understanding of quality principles and practices, as well as experience in complaint handling and root cause analysis. What You’ll Be Doing Customer Incident Identification: Promptly identify and document customer complaints from various sources, including customer support channels, social media, and field reports.  Accurately classify and categorize complaints based on type, severity, and potential root cause. Complaint Triaging: Prioritize complaints based on urgency, potential impact, and regulatory requirements.  Assign complaints to appropriate team members for investigation and resolution. Complaint Resolution: Conduct thorough investigations to determine the root cause of customer complaints.  Implement effective corrective actions to prevent recurrence of similar issues.  Provide timely and accurate responses to customers, keeping them informed of the progress of their complaint resolution. Complaint Disposition: Document and close out resolved complaints, ensuring all relevant information is captured and retained.  Provide periodic reports to management on complaint trends, root causes, and corrective actions taken. Collaborate with Regulatory Affairs/Quality Systems team and Periodically analyze and review Complaint Controls process to stay in compliance with latest applicable Regulations and Standards. 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. May lead or manage team members. Follow regulatory and ISO 13485 requirements What You’ll Bring to the Team Bachelor's degree in Engineering, Quality Assurance, or a related field. 3+ years of experience in complaint handling, preferably in a genomics or medical device environment. 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.  ISO 13485:2016 Lead Auditor Certification  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.    About Twist Bioscience Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA. At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers. Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law. 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 $100,000 — $125,000 USD