Steven Tran

I’m a Life Sciences Quality & Operations leader with 6+ years of experience in diagnostics, medical devices, and high-growth manufacturing. I specialize in scaling quality systems, navigating regulatory requirements, and enabling efficient, compliant product launches. My background spans both strategic programs and hands-on operational transformations.

At COPAN Diagnostics, I guided the company to its first TÜV ISO-13485 certification and led a site-wide transformation to reposition the business in the post-COVID market. These efforts enabled accelerated entry into the Infectious Diseases IVD (point-of-care, at-home, OTC) market, launching 10+ high-volume SKUs that generated $1M–$10M in revenue.

I have bridged strategy and execution, partnering with start-ups and Fortune 500s to shape quality and regulatory strategy, implement digital transformations, and scale operations. Throughout my career, I built and led cross-functional, best-in-class class teams that consistently delivered regulatory readiness, operational efficiency, and accelerated market access.

Core Competencies:
- QMS Implementation, Optimization, and Scaling
- Quality & Regulatory Compliance (ISO-13485, MDSAP, 21 CFR 820)
- Regulatory Submission Support
- CAPA & Change Control
- Product Development & Market Access Acceleration
- Strategic Planning, Operational Scaling & Supplier Management
- Digital Transformation & Agile Delivery in Life Sciences
- Team Building & Upskilling
- Executive Advisory, Stakeholder Engagement & Cross-Functional Leadership

Autonomous Medical Devices Incorporated | Santa Ana, CA        

Senior Quality Engineer

June 2024 - Present             

• Leading new product introduction (NPI) initiatives for rapid, point-of-care respiratory and STI diagnostics systems, ensuring compliance with ISO-13485, 21 FDA CFR 820, & MDSAP and enabling market entry into IVD space.
• Authoring lean manufacturing procedures and facilitating process mapping sessions (formulations, lyophilization, assembly, packaging), translating complex workflows into compliant documentation aligned with regulatory standards.
• Reduced clinical study and product launch timelines by 50%, managing controlled document and part approval workflows in Oracle Product Lifecycle Management (PLM) and NetSuite Enterprise Resource Planning (ERP) software while coordinating SME reviews and approvals.
• Owning development and deployment of executive-level dashboards to track product development progress, quality management system (QMS) key process indicators (KPIs), and continuous improvement initiatives, enabling agile executive decision-making.
• Serving as internal auditor for ISO-13485 and MDSAP compliance, leading cross-departmental initiatives to resolve nonconformances and identify opportunities for improvement.

COPAN Diagnostics | Carlsbad, CA

New Product Introduction & Quality Engineering Manager

October 2023 - May 2024                                                                 

• Directed customer-facing NPI program including four (4) direct quality engineering and analyst reports on product development engagements with IVD start-ups and Fortune 500 clients, conducting SWOT and Pareto analyses and securing $1M - $10M in supply agreements to expand IVD market access in post-Covid landscape.
• As part of post-market surveillance activities in collaboration with COPAN Italy, led cross-functional crisis response for Fortune 500 IVD client, applying Six Sigma and Lean methodologies to reduce part defect rates from 20% to <1%, preventing escalation to product recall, and safeguarding customer reputation.
• Partnered with Big Four consultants on eQMS transformation, leading to creation of new standard operating procedures (SOPs) and work instructions (WIs) for product development and change control along with establishment and upskilling of client-facing NPI team.
• Implemented quarterly management reviews and key process indicators for product development, achieving top management buy-in for additional quality team resourcing, training, and certifications (ASQ, Six Sigma).

Quality Assurance Manager

March 2021 - October 2023                                                                 

• Led new product introduction activities as customer-facing lead and implemented site-level product development & contract manufacturing capabilities in compliance with 21 CFR 820.30 Design Controls.
• Led value stream mapping workshops with key stakeholders and SMEs to optimize new product introduction and change management processes, reducing launch timelines by 50% and introducing 10+ novel, high-volume sample collection SKUs to portfolio.
• Via supplier corrective action process, negotiated a no-cost replacement of one million defective raw material units valued at $300K with an Asia-Pacific supplier, safeguarding delivery timelines during peak of respiratory season.
• Implemented design control and manufacturing ramp-up plan to meet supply demand with a Fortune 500 IVD customer, converting user requirements to clinical study-ready sample collection and transport kits in 3 months.
• Acted as primary audit liaison, achieving initial ISO-13485 TÜV certification and successfully managing over ten internal, surveillance, & customer audits over the course of two years.

Quality Assurance Specialist

May 2020 - March 2021                                                                 

• Led ISO-13485 QMS and manufacturing process implementation in collaboration with Apple and Big Four consultants at new, high-volume Carlsbad manufacturing site, enabling ramp-up to 1M units per week to meet COVID-19 testing demand.
• Deployed Swim Lane process map and training plan to upskill 100+ operators and quality personnel in one month on GxP, manufacturing automation, enterprise resource planning (ERP), batch history record review, and lot release, enabling 24/7 production as part of pandemic response.
• Integrated Navision ERP & Excel Power Query, launching executive-facing dashboard detailing supply chain current state from raw material receipt to production and sales order fulfillment.
• Successfully managed over ten CAPAs using Ishikawa and 5-Why methodologies to remediate GxP, Environmental Control, Aseptic Filling, and Identification & Traceability systemic issues, closing procedural and process gaps as part of continuous improvement and audit preparation activities.

Becton, Dickinson and Company | San Diego, CA

Quality Assurance Specialist

May 2019 - May 2020                                                                 

• Drafted and executed IQ/OQ/PQ validation procedures for BD Alaris Infusion Disposables terminal sterilization (Gamma, E-Beam, and EO) in accordance with ISO-13485, -11135, and -11137 requirements.
• As part of NPI activities for BD Alaris Infusion Disposables, prepared feasibility analysis and co-pitched an E-Beam Sterilization Expansion Project with projected $2M per year cost savings.

University of California, San Diego | June 2017                               

B.S., Bioengineering