Senior Manufacturing Quality Engineer Manager

Devonshire_Jobs Senior Manufacturing Quality Engineer Manager

Job Overview:

Devonshire Recruiting & Consulting Partners is in search of a Lead Quality Engineer in Medical Device Manufacturing, to ensure compliance and drive continuous improvement. Part of their responsibilities will be to oversee nonconformance processes, analyze production data, and collaborate on process controls. Manage inspection of raw materials and finished products, resolving yield issues. Support internal audits and contribute to the Company’s mission and vision.


Key Responsibilities:


  • Provide expertise in quality engineering for the manufacturing of medical devices and hardware.
  • Ensure strict compliance of manufacturing processes and areas with all relevant quality system regulations.
  • Spearheaded the Nonconformance (NCMR) process, overseeing inspection methods, containment, correction, closure, and CAPAs, and fostering continuous improvement through trend data analysis.
  • Monitor and analyze production information to guide risk management and provide insights for corrective and preventive actions or process improvements.
  • Collaborate with manufacturing engineering to establish and validate necessary process controls, adhering to best practices (GMP).
  • Supervise the inspection and testing of raw materials, components, and finished products to guarantee compliance with specifications and quality standards.
  • Establish and uphold quality control procedures, including inspection methods and test protocols.
  • Address incoming inspection yield issues by enhancing vendor process capabilities, ensuring accurate internal drawing specifications, and validating inspection methods.
  • Lead the analysis of defective components identified in Incoming Inspection, collaborating with suppliers to resolve issues (SCARs).
  • Support internal auditing requirements in manufacturing to ensure full compliance with quality system requirements.




  • Possess a minimum of 8 years of experience in a Manufacturing Quality and/or Manufacturing Engineering role, with a minimum of 4 years of responsibility for Product Quality and/or Quality Systems.
  • Exhibit a solid understanding of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485, and other relevant regulations and industry standards for Medical Devices.
  • Demonstrate experience in manufacturing complex products within an environmentally controlled area, with a preference for familiarity with medical capital equipment and electromechanical devices.
  • Proficient in formal problem-solving methodologies, root cause analysis, and CAPA.
  • Have experience in handling non-conforming materials and assemblies.
  • Possess practical knowledge and experience using Minitab or other statistical analysis tools, with an understanding and application of Gage R&R and Measurement system analysis.
  • Utilize statistical data analysis for trending purposes, ideally employing Six Sigma methods and tools.
  • Demonstrate effective communication skills, conveying ideas and information clearly and concisely.
  • Education: Hold a BS in Mechanical, Electrical, or Biomedical Engineering, or another scientific or related discipline.

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