Quality Engineer

Support design quality, risk management, quality systems, and technical documentation for regulated product development and manufacturing activities.

Job Requirements

• Bachelor’s degree in Engineering or a related technical field
• One to three years of experience in a regulated industry
• Experience or coursework in design controls
• Experience or coursework in risk management and FMEA
• Experience with requirements traceability
• Working knowledge of Quality Management System concepts
• Knowledge of CAPA processes
• Knowledge of change management processes
• Knowledge of document control requirements
• Experience creating and maintaining technical documentation
• Experience analyzing technical or quality data
• Experience investigating nonconformances
• Knowledge of root cause analysis methods
• Experience with basic statistical analysis tools

Preferred Skills

• Experience within medical device, aerospace, pharmaceutical, or another regulated industry
• Experience supporting product development under formal design control processes
• Experience with risk management documentation
• Experience with requirements management or traceability tools
• Experience using Pareto analysis
• Experience using fishbone diagrams
• Experience with basic Statistical Process Control
• Experience supporting CAPA investigations and change control activities

Job Responsibilities

• Support design control activities throughout the product development lifecycle
• Develop and maintain design quality documentation
• Support risk management activities, including FMEA development and updates
• Maintain traceability between product requirements, design outputs, and verification activities
• Support Quality Management System processes
• Assist with CAPA investigations and corrective action activities
• Support engineering change management and document control processes
• Review and maintain technical documentation for compliance with quality requirements
• Analyze quality and engineering data
• Investigate product and process nonconformances
• Perform root cause analysis using applicable quality tools
• Develop Pareto analyses, fishbone diagrams, and basic SPC evaluations
• Support verification, validation, and design review activities
• Maintain quality records associated with regulated product development

Pay Details: $30.00 to $38.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.