Senior Manufacturing Quality Engineer

2 weeks ago

Maple Grove, Minnesota, United States 4 C Medical Technologies Full time

We are seeking a detail-oriented and collaborative Senior Manufacturing Quality Engineer (Sr. QE) to support the design, development, and commercialization of transcatheter mitral heart valve technologies. This role is responsible for ensuring compliance with global regulatory and quality requirements, including FDA QSR, ISO 13485, ISO 5840 and EU MDR. The Sr. QE leads our quality assurance efforts in our manufacturing processes. The ideal candidate will have hands-on experience with process validation, process optimization, manufacturing, and the development of Class III medical devices.

Essential Job Functions

Validation and Compliance

  • Lead and execute process validation activities for new and existing manufacturing processes, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
  • Lead and execute software validation activities for manufacturing and quality systems, including establishing validation protocols, performing testing, and documenting results.

Quality Assurance and Improvement

  • Develops and implements quality assurance policies, procedures, and standards in compliance with ISO 13485:2016.
  • Plan, conduct, and report internal audits per ISO 13485:2016 requirements and company audit schedules.
  • Support nonconformance investigations (NCMRs), CAPA activities, and root cause analysis for manufacturing deviations and process issues.
  • Lead root cause analysis and corrective action initiatives for quality issues
  • Collaborates with cross-functional teams to improve manufacturing processes and product quality
  • Analyzes quality data and metrics to identify trends and areas for improvement
  • Review and approve manufacturing process changes, ensuring compliance with regulatory requirements.

Facility and Environmental Oversight

  • Oversee cleanroom qualification and environmental monitoring programs, reviewing reports and ensuring documentation meets ISO 14644 and GMP expectations. 

Leadership

  • Foster a positive culture of growth, collaboration, and achievement across the organization
  • Provide directions to extended and core team members. Defines, organizes, and manages individual and team tasks.
  • Provide a structured and methodical approach to problem-solving.
  • Work independently with minimal direction in a fast-paced, constantly changing environment 

Requirements

Education, Certifications, Experience and Other Skills

  • Bachelor's degree in Engineering, preferably in Manufacturing, Mechanical, or Industrial Engineering
  • 7+ years of experience in manufacturing quality engineering
  • Certified Internal Auditor (ISO 13485:2016) or equivalent preferred
  • Experience with lean manufacturing principles and Six Sigma methodologies
  • Experience supporting PMA and CE Mark submissions for Class III medical devices.
  • Demonstrated experience with design controls, risk management, DHF documentation, and process/test method validation.

Knowledge, Skills and Abilities

  • Strong knowledge of quality management systems and statistical process control
  • Demonstrated 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.
  • Strong understanding of design controls, risk management, statistics, test method validation, and new product development processes.
  • Strong understanding of industry regulations such as ISO13485 and FDA QSR's
  • Able to handle and be trusted with confidential and/or sensitive information.
  • Able to be flexible and handle multiple projects in an organized, timely manner.

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