Manufacturing Quality Engineer

SUMMARY

The Manufacturing Quality Engineer ensures product quality and process compliance within a regulated medical device environment. This role is essential for driving continuous improvement, performing root cause analysis, executing process validation/equipment qualification, and maintaining strict adherence to quality system regulations (ISO 13485, FDA QSR, EU MDR). The Engineer provides technical guidance to manufacturing operations and collaborates cross-functionally to uphold the highest standards of quality and safety. 

ESSENTIAL FUNCTIONS

• Lead the identification, documentation, segregation, and disposition of nonconforming materials, ensuring timely investigation, appropriate review by MRB, and trending activities
• Participates in root cause analysis and corrective action initiatives for manufacturing related quality issues
• Participates in quality audits to ensure compliance with industry standards and regulations
• Collaborates with cross-functional teams to improve manufacturing processes and ensure product quality
• Supports inspections on the manufacturing floor
• Mentors, guides and trains quality technicians
• Helps to ensure compliance with ISO 13485, FDA QSRs (820), EU MDR and other relevant regulatory requirements
• Participates in new product development and process validation activities
• Ideal candidates have process validation and equipment qualification experience.
• Foster a positive culture of growth, collaboration, and achievement across the organization.

Requirements

EDUCATION

• Bachelor's degree in Engineering, preferably in Manufacturing, Mechanical, or Industrial Engineering

EXPERIENCE 

• 2 – 3 years of experience in manufacturing quality engineering or other QA discipline
• Experience with lean  manufacturing principles and Six Sigma methodologies
• Preferable for candidate to have experience working with Class III implantable devices, specifically heart valves

KNOWLEDGE, SKILLS AND ABILITIES

• Strong knowledge of quality management systems and statistical process control
• Strong understanding of industry regulations such as ISO13485, FDA QSRs, and EU MDR
• Familiarity with relevant industry standards and regulations (e.g., ISO 13485, FDA QSRs, EU MDR)
• Strong understanding of design controls, risk management, statistics, test method validation, and new product development processes.
• Excellent analytical and problem-solving skills
• Strong leadership and communication abilities
• Proficiency in quality management software and data analysis tools
• Effective verbal and written communication. 
• Proficiency in technical report writing and review.
• Interpersonal skills; working in a team and as an individual contributor.
• Structured and methodical problem-solving approach.
• Ability to handle and be trusted with confidential and/or sensitive information.
• Ability to work in a fast-paced, constantly changing environment.
• Ability to be flexible and to handle multiple projects in an organized, timely manner.
• Ability to work independently, with a sense of urgency and with minimal direction.
• Ability to define, organize, and manage individual and team tasks.