Reference Number: JO-2309-522369
Quality Engineer Lead
Rate: Negotiable
Job Type: Permanent
Location: United States

My client a leading Medical Device manufacturer is currently recruiting for a Quality Technician Lead to join their talented team.

The requirements of the Quality Technician Lead are as follows  

  • Able to independently perform a wide range of quality assurance duties under general guidance from supervisor
  • Experience in medical device manufacturing preferred but other manufacturing-based business experience may be acceptable
  • Background with ISO 13485 and FDA GMPs (preferred) or ISO 9000 quality system requirements
  • Knowledge of quality methods, tools, instruments
  • Ability to read drawings with a full understanding of geometric and electronic measurements and tolerances
  • Ability to use and understand hand measurement tools and electronic test instruments
  • Strong communication skills and the ability to interface with a wide variety of disciplines throughout the organization
  • Strong statistical, analytical and problem-solving skills
  • Proficient with MS office products (Word, Excel, Powerpoint)
  • Must be able to perform electrical testing of electronic medical devices


  • Actively participate in continuous improvement /corrective action activities of quality related processes and ensure the right application of Quality tools and expertise
  • Provides technical expertise in problem solving tools to lead root cause investigations
  • Quality review / verification of critical information related to the receipt of incoming goods or the distribution of finished goods for customer orders
  • Ensures compliance of incoming materials prior to use in Manufacturing Operations
  • Inspection of incoming, in-process and final parts or product per established sampling plans and procedures
  • Executes process validation protocols and assists with report review
  • Other related duties as required or assigned

Incoming Inspection

  • Perform incoming inspection and acceptance activities for received materials and components
  • Receipt, verification and record retention of Certificate of Compliance and Certificate of Analysis documentation

Monitoring & Reporting

  • Record and trend temperature and humidity data of production and storage areas (as required)
  • Conducts Housekeeping audits and verifies cleaning records are completed as required
  • Perform audits of in-process testing to ensure compliance to documented procedures and specifications
  • Reporting of inspection/audit results to proper groups as needed
  • Provides information and data reflecting the status of the local site quality system
  • Prepares a monthly Quality Report
  • Supports / provides inputs to review forums (e.g. Management Review, Periodic Safety Update Report (PSUR) and Post Market Clinical Follow Up Report (PMCR))

Containment, Nonconformance, CAPA Management

  • Inspection/containment of suspect non-conforming parts or product
  • Write and process product nonconformance reports
  • Inspection/verification of corrective action effectiveness on parts or product supplied after SCAR response and CA implementation
  • Assists with corrective action and process improvement activities and assists in appropriate re-training
  • Monitors suppliers and manages SCAR process with suppliers for local site issues and provides US support for Corporate supplier issues as required

QMS Compliance

  • Understand all quality management system requirements and applicable US Regulatory requirements
  • Ensure compliance of site quality management system and production activities to maintain a state of continuous audit/inspection readiness
  • Leads/Hosts all local site activities relevant for FDA, ISO 13485, customer and other regulatory audits
  • Maintains local site quality training programs, ensures timely completion of training and records
  • Provides backup support for the QA Manager in a variety of functions
  • Provide assistance with audit prep work and document retrieval during audits
  • Provide quality knowledge to production team members when needed

Production Quality

  • Verify proper production line clearance is performed prior to production set up
  • Verify staged production materials and labelling against workorder, BOM, and DMR documentation
  • Verify production is set up according to build instructions and required equipment is available and calibrated
  • Ensures levels of cleanliness for components and equipment used in the manufacturing process meet the company standards
  • Perform in process and final inspections according to established test methods

Final Product Release

  • Verifies accurate and complete documentation of manufacturing steps and in-process and final tests/inspections performed within device history record (DHR) including maintenance of raw test data and files within travelers
  • Completes final release report and coordinates final release approval with Quality Manager
  • Communicates final release to production and planning

Change Management

  • Support Design Engineering, Manufacturing Engineering and production teams to ensure design drawings, manufacturing instructions, inspection instructions, equipment, and tooling are developed in a consistent, appropriate, and complete manner
  • Verify implementation and verification of engineering and document change orders


  • Assist in the coordination of calibration services
  • Verifies results of calibration reports and certificates and ensures proper records are maintained
  • Ensures out of calibration equipment is removed from production areas and quarantined
  • Maintain calibration status lists

Environmental Health and Safety (EHS)

  • Demonstrate a Safety-First mindset, proactively adhere to and promote all Safety Policies and Procedures
  • Follows established guidelines for safe material handling and protective gear
  • Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes
  • Assist in the organization and housekeeping of the production and support areas
  • Maintain a clean and safe work area and report unsafe conditions to management
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