Position Overview

We are seeking an experienced Manufacturing Quality Engineer to support the development and commercialization of innovative transcatheter mitral valve technologies. This role plays a critical part in ensuring manufacturing processes meet the highest standards for quality, safety, and regulatory compliance.

The ideal candidate brings strong experience in process validation, quality systems, and Class III medical device manufacturing, along with a collaborative mindset and a passion for improving manufacturing processes and product quality.

Key Responsibilities

Validation & Regulatory Compliance

• Lead process validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing manufacturing processes.
• Execute software validation for manufacturing and quality systems, including protocol development, testing, and documentation.
• Ensure compliance with FDA QSR, ISO 13485, ISO 5840, and EU MDR requirements.
• Support regulatory submissions including PMA and CE Mark documentation related to manufacturing and quality processes.

Quality Assurance & Continuous Improvement

• Develop and maintain quality policies, procedures, and standards aligned with ISO 13485:2016.
• Plan, conduct, and report internal quality audits in accordance with ISO requirements.
• Lead investigations into nonconformances (NCMRs) and support CAPA activities.
• Conduct root cause analysis for manufacturing deviations and quality issues.
• Analyze quality data and performance metrics to identify trends and drive continuous improvement.
• Review and approve manufacturing process changes while ensuring regulatory compliance.
• Collaborate cross-functionally to enhance manufacturing efficiency and product quality.

Facility & Environmental Oversight

• Oversee cleanroom qualification and environmental monitoring programs.
• Review environmental data and ensure compliance with ISO 14644 and GMP requirements.
• Maintain documentation supporting facility compliance and audit readiness.

Leadership & Collaboration

• Promote a culture of quality, accountability, and continuous improvement.
• Provide direction and guidance to project teams and cross-functional partners.
• Apply a structured and analytical approach to problem solving.
• Manage multiple priorities while working effectively in a fast-paced and evolving environment.

Qualifications

Education

Bachelor’s degree in Engineering (Manufacturing, Mechanical, Industrial, or related field preferred).

Experience

• 7+ years of experience in Manufacturing Quality Engineering within the medical device industry.
• Experience supporting Class III medical device development and manufacturing.
• Experience supporting PMA and/or CE Mark submissions preferred.
• Background in process validation, test method validation, and manufacturing process development.

Certifications (Preferred)

• Certified Internal Auditor (ISO 13485:2016) or equivalent certification
• Experience with Lean Manufacturing and Six Sigma methodologies

Knowledge, Skills & Abilities

• Strong understanding of Quality Management Systems (QMS) and statistical process control
• Knowledge of FDA QSR, ISO 13485, ISO 5840, and medical device regulatory requirements
• Experience with design controls, risk management, and DHF documentation
• Proficiency with quality management and data analysis tools
• Excellent technical writing and documentation skills
• Strong communication and cross-functional collaboration skills
• Ability to manage multiple projects and shifting priorities

Compensation

Salary Range: $100,000 – $145,000 (based on experience and qualifications)

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