Senior Quality Engineer

We are seeking an experienced Senior Quality Engineer to join our venture-backed startup, Bioskryb. As a Senior Quality Engineer, you will play a crucial role in establishing and implementing quality systems for the design and manufacture of novel genome amplification applications. Your responsibilities will include providing ongoing quality engineering support throughout the product life cycle, supporting validation planning and transfer activities, and ensuring compliance with internal quality requirements. Additionally, you will be responsible for conducting quality audits, driving product risk management activities, and identifying opportunities to improve quality system processes. Join us in revolutionizing the field of genomics and making a significant impact in diverse markets such as cancer genomics and personal genomics.

• Provide ongoing quality engineering support for new single cell products based on the core technology
• Support R&D and manufacturing teams in validation planning and transfer activities
• Assist in determining validation needs and requirements
• Support engineering change controls, deviation management, and document change management
• Assist with the development and implementation of a Quality Management System (QMS)
• Establish a process for complaint, non-conformance, and Corrective and Preventive Actions (CAPA) records
• Assess and qualify new suppliers and materials
• Conduct quality audits of contract manufacturing partners and suppliers
• Drive product risk management activities
• Ensure quality and completeness of project design history files, validation packages, and change orders
• Review verification and validation reports for compliance to internal quality requirements
• Establish a dashboard with Key Performance Indicators (KPIs)
• Develop and execute strategies to close quality gaps
• Coordinate issue resolution using a risk-based approach
• Identify areas and opportunities to improve quality system processes and product issues
• Trend, analyze, and report on quality data to improve product and process
• Own and/or coordinate Corrective and Preventive Actions (CAPAs) and Non-Conformance Reports (NCRs)

• Experience in quality engineering in the design and manufacture of genome amplification applications
• Knowledge of Primary Template Directed Amplification (PTA) technology
• Familiarity with validation planning and transfer activities
• Understanding of engineering change controls, deviation management, and document change management
• Ability to develop and implement a Quality Management System (QMS)
• Proficiency in complaint, non-conformance, and Corrective and Preventive Action (CAPA) records
• Experience in assessing and qualifying new suppliers and materials
• Knowledge of quality audits for contract manufacturing partners and suppliers
• Understanding of product risk management activities
• Familiarity with verification and validation reports
• Ability to develop and execute strategies to close quality gaps
• Proficiency in analyzing and reporting on quality data
• Experience in coordinating Corrective and Preventive Actions (CAPAs) and Non-Conformance Reports (NCRs)

• Participation in technical discussions and risk-based decision making
• Review verification and validation reports and identify gaps for compliance to internal quality requirements
• Establish a dashboard with the appropriate KPI's
• Develop and execute strategies to close quality gaps in an efficient, technical, and compliant manner
• Coordinate issue resolution using a risk-based approach
• Identify areas and opportunities to improve quality system processes and product issues
• Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
• Own and/or coordinate CAPAs and NCRs
• Practical experience in design controls, risk management, validation, change control, and supplier quality
• Experience with CAPA and failure investigation tools and techniques
• Applied experience with quality and statistical analysis tools (e.g., SPC, 6 Sigma, Risk Analysis, FMEA, DOE, and trend analysis)
• Adaptable to fast-paced, less structured, dynamic work environment with shifting demands
• Demonstrated ability to accomplish goals while working across departments is required
• Experience with CLIA Certification
• 7-10 years' experience in quality assurance working in the life sciences or medical device industry with a BS or MS degree
• Demonstrated experience implementing quality systems in a startup environment
• Experience in Genomics, Immunology, Biology, or a relevant field preferred
• Equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law