Quality Engineer II

We are seeking a Quality Engineer II to enhance the quality assurance practices of our 3-D printer manufacturing operations. Focused on advancing our commitment to delivering high-quality devices, this role involves deep collaboration with both local and offshore contract manufacturers to enforce and elevate our quality standards. The successful candidate will spearhead the development and refinement of quality assurance protocols, ensuring our devices consistently exceed both regulatory and customer expectations.

Core Responsibilities:

• Quality Assurance Strategy: Develop and refine quality assurance protocols and strategies to align with industry best practices, with an emphasis on improving device reliability and performance.
• Quality Standards Compliance: Ensure all products meet strict quality standards and compliance requirements, including familiarity with relevant quality management systems (e.g., ISO 9001) as a framework for excellence, even though direct ISO certification may not be applicable.xa
• Audit and Assessment: Conduct regular quality audits and assessments of internal processes and those of our contract manufacturers to identify areas for improvement, focusing on overall device quality as produced at our external partner manufacturing facilities.
• Corrective and Preventive Actions: Lead the identification, development, and implementation of corrective and preventive actions (CAPA) to address quality issues, ensuring the root causes are effectively addressed.
• Root Cause Analysis: Assist in diagnosing product failure root cause and developing work instructions for refurbishment engineering activities.
• Quality Metrics and Reporting: provide updates for tracking and reporting on key quality metrics, using data to drive decisions and improvements in device quality assurance practices.
• Supplier Quality Management: Work closely with suppliers and contract manufacturers to establish and maintain high-quality standards, conducting supplier audits and manage first article inspection activities to ensure compliance with our quality requirements.
• Stakeholder Collaboration: Facilitate communication and collaboration between internal teams and external partners to support customer expectations through warranty activities.

Qualifications:

• Strong foundation in quality engineering principles, with a focus on quality assurance.
• Proven track record of improving product quality and reliability in a technology-driven industry.
• Experience with quality standards, compliance, and certification processes, with a preference for candidates familiar with ISO 9001 principles.
• Excellent analytical and problem-solving skills, capable of conducting thorough quality audits and implementing effective CAPA initiatives.
• Exceptional communication and collaboration skills, able to work effectively with both internal teams and external manufacturing partners.
• Willingness to travel as needed for supplier evaluations and quality audits.
• 3-5 years of experience in a quality assurance role, specifically within a high-tech or device manufacturing environment.

Important Note: Although we list out what we generally look for, we are very likely missing other attributes and skills that you have that could make you a great fit, but are not currently listed. Research has shown this especially applies to women and other marginalized groups, who tend to apply if they check 100% of every box, versus men who apply if they hit roughly 60%. The point we’re getting at, it doesn’t hurt to take a chance and apply!