myGwork - LGBTQ+ Business Community · 3 days ago
Quality Engineer III
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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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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
Benefits
401(k) with company match up to 6%
Tuition reimbursement
Annual incentive bonus plan
Company
myGwork - LGBTQ+ Business Community
myGwork is the largest global platform for the LGBTQ+ business community.
Funding
Current Stage
Early StageTotal Funding
$4.77MKey Investors
24 HaymarketInnovate UK
2023-08-17Series Unknown· $1.66M
2023-08-17Grant· Undisclosed
2021-12-07Series A· $2.12M
Recent News
2024-04-10
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