Quality Engineer Lead

United States • Negotiable • Permanent, Full time

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

Website: Cpl Life Sciences

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