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Original Job Post

myGwork - LGBTQ+ Business Community · 3 days ago

Quality Engineer III

Seattle, WA

Full-time

Onsite

Senior Level

$83K/yr - $125K/yr

5+ years exp

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Responsibilities

Ensure operations, processes, and procedures affecting product quality and/or integrity align with ISO 9001:2015; 47 CFR 15 Subpart B, and EN 61326-1:2013 requirements

Support Operations to ensure that products and processes stay in sync with the relevant requirements of the quality and environmental health and safety management system

Maintain quality tracking systems, and analyze non-conformance trends to select improvement priorities

Lead Management Reviews to identify improvements and supervise progress of continuous improvement

Complete and evaluate the effectiveness of corrective actions

Conduct internal audits including product inspections

Provide Quality Management System (QMS) awareness at the Seattle location via activities and training.

Respond to quality issues and actions based on requests from Service, Sales, and Customers

Assist site team in establishing, implementing, and maintaining standard operating procedures

Create and maintain process/product documentation such as manuals, quality procedures, etc.

Lead projects using effective project management skills

Supervise and develop a Quality Specialist

Review physical products and documentation, including customer requirements, prior to shipping products

Develop supplier performance and measurable indicators to monitor performance

Work well with operations to ensure quality control is properly integrated and maintained at critical inspection points

Shepherd engineering and process changes through an E/DCO process

Qualification

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Quality assurancePharmaceutical industryTechnology manufacturingQuality certificationSix-sigmaIsoLeanProduct certificationsCe markingEmc testingFda certificationsImprovement methodologiesAuditingStatistical methodsIso 9001Manufacturing processesSupply chain managementProject managementData analysisProblem-solvingCommunicationTeamworkAdaptability

Required

Bachelor's degree in a technical field such as Quality, Industrial, or Manufacturing Engineering

5+ years experience in Quality Assurance, preferably in Pharmaceutical or Technology Manufacturing Industry

Quality certification expertise (e.g. Six-Sigma, ISO, Lean) preferred

Experience with product certifications a plus. Particularly, certifications for CE marking, EMC testing, and FDA certifications.

Knowledge of improvement methodologies (e.g. Lean, 6-sigma), auditing experience (leading internal or supplier audits), and statistical methods

Experience with ISO 9001 or similar quality standards

Knowledge of Manufacturing and Supply Chain Management processes for complex high tech, low volume systems

Demonstrated results in improving quality in manufacturing or development processes

Proven track record to managing complex projects from inception to completion

Solid data analysis skills that may involve multiple factors and multi-functional areas

Must demonstrate good communications skills and be able to work effectively with multi-functional teams on projects including international and multicultural teams and suppliers and customers

Able to adjust working times to accommodate communications with other facilities, suppliers and customers across the globe

Comfortable working within a small factory environment dealing with sophisticated, high-tech products