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Manufacturing and Quality V&V Lead

Manufacturing and Quality V&V Lead

VerAvantiBothell, WA, US
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Job Description

Job Description

Salary : $80K - $100K

Job Title : Manufacturing and Quality V&V Lead

Company Overview

VerAvanti is an innovative medical device company specializing in precision imaging catheters and interventional tools. We plan on becoming the Intravascular eyes for coronary Interventionalists. Our mission is to advance healthcare through cutting-edge technology that enables minimally invasive diagnostics and treatments. We foster a collaborative environment where ones creativity and attention to detail, drive our success in developing life-changing products

Job Summary

We seek an engineer or senior technician experienced in Verification and Validation (V&V), root cause analysis, and lean manufacturing techniques. This hybrid Quality / Manufacturing role transforms R&D Nano processes into Pre-Production Design Freeze for 'First in Human' parts. The role focuses on owning quality inspection processes and documents supporting semiconductor and micro-assembly, as well as reviewing and optimizing these manufacturing processes. Theres an opportunity to contribute ideas for new products and improve manufacturability, quality, and cost of existing products.

The ideal candidate has experience in both manufacturing and quality engineering, is a hands-on problem-solver with strong root cause analysis skills, and thrives in a collaborative team setting. The position offers equity participation, competitive benefits, and professional growth.

Key Responsibilities

  • Develop and maintain quality management systems aligned with ISO standards.
  • Review, optimize, validate, and verify manufacturing processes to ensure quality and regulatory compliance.
  • Lead root cause analysis, CAPA, and nonconformance investigations with proper documentation.
  • Conduct internal and external audits of processes, materials, and suppliers, supporting regulatory inspections.
  • Monitor production data, track quality trends, and drive continuous improvements.
  • Manage supplier quality through evaluations and audits.
  • Provide training and mentoring on quality systems, GMP, and process controls.
  • Oversee documentation control, including Control Plans, Inspection Plans, and Device History Records.

Qualifications

  • Bachelors degree in Manufacturing, Mechanical, Biomedical, or Industrial Engineering, or 8+ years in a similar role.
  • 3+ years in a regulated environment, preferably medical devices.
  • Experience in small-scale assembly (semiconductors, micro-assembly, micro-fluidics, PCBA) is a plus.
  • Experience writing and executing V&V plans.
  • Strong knowledge of QMS systems relevant to medical devices, including CAPA, training records, and change control.
  • Familiarity with ISO 13485 and EN 13485 quality management standards.
  • Proficient technical writer comfortable with internal and FDA reviews.

    • Required Skills and Attributes

  • Expertise in manufacturing and quality engineering to improve yields, reduce cycle times, and enhance processes.
  • Comfortable with pre-production environments involving lower volumes and frequent documentation changes.
  • Detail-oriented quality checker with a desire for mistake-proofing and data review.
  • Knowledge of precision engineering fundamentals : GD&T, materials, manufacturing methods, Gauge R&R, and root cause analysis.
  • Clear and effective communicator with both technical and non-technical stakeholders.
  • Proven team player who contributes to collaborative problem solving.
  • Proficiency in Microsoft Office and engineering analysis tools like FEA software.

    • What We Offer

  • Competitive market salary commensurate with experience.
  • Comprehensive healthcare benefits, including medical, dental, and vision coverage.
  • Generous Paid Time Off (PTO) policy to support work-life balance.
  • Equity participation opportunities allowing you to share in the company's success.
  • Professional development resources, including training and conference attendance.
  • A supportive, inclusive workplace with flexible hours and opportunities for advancement.

    • If you are a driven engineer passionate about transforming healthcare through precision design, we encourage you to apply. Please submit your resume and a portfolio of relevant work to Bamboo HR link or visit our careers page. We are an equal opportunity employer.

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    Quality Manufacturing • Bothell, WA, US