Job Description

Job Description: Quality Engineer II

About Our Client

Our client is a pioneering medical device company focused on developing the world’s first fully implantable, Class III cardiovascular implantable product. Their team is driven by a powerful purpose: to transform the lives of patients with end-stage heart failure by delivering innovative, reliable, and life-saving cardiac technology. Join them as they continue advancing toward clinical use and commercialization.

Position Summary

Our client is seeking a Quality Engineer II to join their team, with a primary focus on working with external suppliers to investigate and resolve Non-Conformance Reports (NCRs). This role is pivotal in ensuring that incoming materials and supplier processes meet stringent quality standards for their Class III cardiovascular implantable product.

The ideal candidate thrives in fast-paced, regulated environments and is adept at supplier collaboration, root cause analysis, and detailed technical writing. Frequent travel (35% or more) is expected to visit suppliers for audits, investigations, and quality improvement initiatives.

Key Responsibilities

• Lead supplier NCR investigations, from initial issue identification to root cause determination and corrective action verification.
• Develop, author, review, and maintain comprehensive NCR documentation in compliance with ISO 13485, 21 CFR 820, and other applicable regulations.
• Participate in document control, training, and change control activities.
• Support CAPA investigations and root cause analysis.
• Assist with internal and external audits and inspection readiness.
• Collaborate closely with suppliers to ensure timely closure of quality issues and effective corrective/preventive actions (CAPA).
• Conduct on-site supplier audits and process inspections; provide technical guidance to address non-conformances.
• Partner with internal teams (R&D, Manufacturing, Regulatory Affairs) to ensure supplier-provided materials meet design and manufacturing requirements.
• Develop and maintain supplier quality agreements, inspection criteria, and control plans.
• Support quality system compliance activities and contribute to continuous improvement projects.
• Help ensure compliance with FDA QSR, ISO 13485, ISO 14971, and other applicable standards.
• Support the receiving and inspection of materials and components for quality conformance.
• Assist with identifying and documenting nonconforming product and supporting investigations.
• Contribute to supplier evaluations and support follow-up on quality-related issues.
• Assist in managing quality records, design history files, and change control documentation.
• Support process validation activities, facility controls, and ensure adherence to good documentation practices.

Key Qualifications

Required

• Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering, or a related field.
• 5+ years of experience in medical device quality or manufacturing, including at least 2 years in Class II (or higher) regulated medical devices.
• Proven experience with supplier quality management, NCR investigation, and CAPA implementation.
• Strong knowledge of ISO 13485, 21 CFR 820, ISO 14971, and related standards.
• Excellent root cause analysis, problem-solving, and technical writing skills.
• Experience reviewing technical documentation for medical or safety-critical software.
• Excellent written and verbal communication skills.
• Ability to travel frequently (35%+), including domestic and international trips to supplier sites.

Preferred

• Experience in Class III medical devices or implantable systems.
• ASQ certification (CQE, CRE, or similar) preferred.
• ISO 13485 auditor experience or training.

What Our Client Offers

• The opportunity to contribute to a life-saving technology at the forefront of medical innovation.
• A collaborative, mission-driven team in a fast-paced startup environment.
• Hybrid work flexibility with the expectation of regular in-office collaboration.
• Competitive salary package and development opportunities.

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