Quality Engineer Lead

Overview

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

General

• 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

Calibration

• 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