Serve as a technical authority and subject matter expert for quality engineering activities across the product lifecycle at TriSalus Life Sciences. The Sr. Quality Engineer provides senior-level technical leadership, mentors junior quality engineers, drives enterprise-wide quality system improvement initiatives, and leads complex cross-functional projects to ensure full alignment with FDA regulations, ISO 13485 requirements, and all applicable standards. This role is distinguished from entry level Quality Engineers by its broader organizational influence, independent project ownership, and role as an internal expert and escalation resource.
- Supplier Controls: Own and lead the supplier quality management program enterprise-wide. Define supplier performance standards, manage the supplier performance monitoring workstream, and drive corrective action activities to prevent recurrence. Develop and execute the supplier management audit schedule; serve as the primary escalation point for critical supplier non-conformances. Provide strategic recommendations for supplier qualification and disqualification decisions.
- Manufacturing Quality Engineering: Serve as the technical authority for manufacturing quality. Lead the development of inspection plans, drive advanced root cause analysis for complex defects, and own continuous improvement initiatives with Sustaining Engineering. Independently assess and resolve systemic quality issues impacting production performance.
- Process Validation / Monitoring: Lead and own process validation and monitoring programs, including IQ/OQ/PQ, Test Method Validation, and Gage R&R. Develop Quality Plans and implement statistically-based product and process quality monitoring. Serve as the internal expert and escalation resource for validation activities across the organization.
- Sterility Assurance: Serve as the organizational subject matter expert for TriSalus sterility assurance compliance. Own the technical relationship with contract sterilization and testing services. Lead process change control, deviation management, BI testing oversight, and periodic requalification/revalidation. Advise R&D and Operations on sterilization strategy and regulatory guidance for new and existing products.
- External Standards: Manage the External Standards workstream. Ensure that the External Regulatory Documents applicable to the TriSalus medical device business (EXT-0001) document is maintained and current based on notifications from regulations and standards publication suppliers. Submit new/revised standards into Veeva Vault in a timely fashion. Help assign and/or perform gap assessments and implement changes for revised standards that impact TriSalus devices..
- Calibration: Lead the development and continuous improvement of in-house calibration capabilities. Define equipment requirements, draft and approve procedures, and oversee training and execution of calibration activities in collaboration with R&D and Operations.
- Internal Audit: Participate in the internal audit program, including serving as lead auditor and audit program owner. Ensure timeliness objectives are met and quality records are properly maintained. Mentor junior engineers in audit methodology.
- Non-Conforming Materials: Drive timely investigation, disposition, and execution activities. Provide performance metrics and trend analysis to leadership; ensure all NCR quality records are properly maintained.
- Corrective and Preventive Actions:. Identify systemic quality issues and trends, lead root cause analysis, and manage corrective and preventive actions to ensure Quality Objectives are met. Provide performance metrics and ensure proper documentation.
- Root Cause Analysis / Statistical Techniques: Serve as the organizational expert in root cause analysis and statistical tool applications. Provide training and coaching across the quality and operations organizations.
- Computer Software Assurance: Lead or provide senior technical oversight to CSA activities. Collaborate with Operations and R&D on software validation and monitoring, including software assessment and revision control.
General:
- Serve as a key participant and technical leader during regulatory site audits (front/back room).
- Generate, review, and approve Quality Plans; provide final sign-off on complex validation and quality documents.
- Generate change orders to ensure procedures comply with current processes and regulations; approve changes initiated by others.
- Prepare and present metrics, trend analysis, and strategic recommendations during Management Review meetings.
- Mentor and develop Sr. Quality Engineers and Associate Quality Engineers; support their professional growth and technical capability.
- Perform final traveler review and finished device release to finished goods as needed.
- Education & Certifications:
- BS in Engineering, Science, Biomedical, or related field required.
- CQA or Lead Assessor certification required.
- CQE certification preferred.
- ASQ Certified Quality Engineer (CQE) or equivalent strongly preferred
- Valid passport required.
- Work Experience:
- 8+ years of Quality Engineering experience in the medical device, pharma, or combination product industry.
- Demonstrated experience leading quality programs, owning complex workstreams, and serving as a technical authority.
- Experience in the manufacture of medical devices or pharmaceuticals required.
- Experience mentoring or developing junior quality engineering staff.
- Experience with intravascular devices a plus.
- Experience with drug product manufacturing a plus
- Knowledge, Skills & Abilities:
- Deep knowledge and application of US and international standards: FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 10993, ISO 11135, ISO 11607, ISO 11737, and ISO 14644.
- Expert-level application of root cause analysis, statistical techniques, SPC, DOE, and problem-solving methodologies.
- Ability to independently lead complex, cross-functional quality projects with minimal supervision.
- Strong technical writing skills; ability to author, review, and approve quality system documents.
- Adept in Microsoft Excel, Minitab, Word, PowerPoint, SharePoint, Outlook, and Teams.
- Demonstrated ability to influence across functions and drive quality culture at an organizational level.
- Excellent communication skills (oral and written); able to present to senior leadership and regulatory authorities.
- Strong sense of urgency, attention to detail, and ability to manage multiple high-priority workstreams simultaneously.
- Physical Requirements:
- Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and applicable federal, state, and local standards.
- Ability to maintain regular, punctual attendance consistent with ADA, FMLA, and applicable standards.
- Must be able to lift and carry up to 30 lbs.
- Must be able to talk, listen, and speak clearly on telephone and video conference.
- Must be able to travel overnight and internationally (<15%).
TriSalus Life Sciences® was established to develop and commercialize disruptive drug delivery technology for the treatment of liver and pancreatic tumors. Our proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach, which has been used in over 18,000 procedures, improves therapy penetration by modulating pressure and flow to overcome the intravascular barriers to therapy delivery. This is a significant step forward in the treatment of liver and pancreatic tumors.
Along with effective drug delivery, we recognize that overcoming immunosuppression in these organs is also important to successful immunotherapy. Because of this, we’ve launched a platform approach that integrates our innovative device technology with a proprietary therapeutic. In 2020 we acquired nelitolimod, an investigational toll-like receptor 9 (TLR9) agonist with the goal of improving outcomes for liver and pancreatic cancer patients. In our phase 1 studies, nelitolimod has demonstrated reversal of immunosuppression and promotion of responses to checkpoint inhibitors.1,2,3,4
In addition to our in-market TriNav® Infusion System and our 510(k) cleared pancreatic delivery system, we are now moving forward with a range of Phase 1 clinical trials in primary liver and pancreatic cancers. We believe we have the potential to transform the treatment of these diseases for patients with limited treatment options.