Senior Staff QA Technician

The Senior Staff Quality Assurance (QA) Technician is responsible for leading and executing failure analysis activities. This includes designing experiments to determine root cause of product failures and reporting data to cross-functional teams.   This includes managing product flow through the lab, inspection of finished goods, support for R&D testing, and partnering with members of the RAQA team to lead failure analysis testing.   

Essential Job Duties and Responsibilities

• Perform inspection and failure analysis/testing of returned devices
• Perform statistical analysis and assist with interpretation of results
• Complete entry/tracking/analysis of data associated with returned devices including refurbished units, RMAs (RFCs, REs) and complaint reports
• Ability to create/update procedures/SOPs/protocols for continuous process improvements
• Work with 3rd party resources for external analysis
• Ability to interface with cross-functional teams including Engineering, Ops, Sales
• In-Process and final inspections for product release, including release of reworked devices
• Perform DHR review activities
• Provide training to QA Tech team on RAQA activities, including complaint management activities
• Assist with the development of product analytical methods
• Provide support for quality system activities (NCMRs, deviations, audit activities, etc.)
• Initiate and lead/assist with activities supporting Non-Conformance Material Reports, CAPA’s and/or SCARs as needed
• Complete RAQA activities as needed
• The Sr. Staff QA Tech may provide line lead support

Skills/Requirements

• Must be able to understand and execute on directions
• Excellent problem-solving skills required
• Must be detail oriented, well organized
• Strong computer and software applications skills
• Must have good oral and written communication skills
• Work effectively to accomplish objectives; ability to execute with minimal instruction
• Ability to provide leadership and guidance to team members is preferred
• Ability to work in assembly line conditions, stand for long periods of time and lift up to 40lbs
• Proficiency with the use of measurement tools such as micrometers, calipers, etc.
• Proficient with computer programs such as Excel and Word
• Strong understanding of FDA, ISO requirements and related requirements for medical device industry
• Experience with Lean Manufacturing, Six-Sigma, and/or other process improvement methodologies (desirable).
• 6+ years minimum work experience required. 

Not accepting third party agency submissions for this role.