Senior Quality Assurance Engineer

Description

Responsibilities

• Compile, monitor and report quality metrics including identifying and/or preparing action plans for improvements
• Support process improvements related to Medical Device Software, Hardware, and Cybersecurity enhancements
• Support timely completion of internal and external audit findings
• Work with teams to define and develop action plans and support timely closure of Corrective and Preventative Actions (CAPA), Complaint Investigations, and Non-Conforming Material Reports (NCMRs)
• Generate quality reports that track cycle times, yields/quality rates, and evaluate trends through Pareto charts for various quality system and product performance metrics
• Lead Quality System improvements from defining requirements, validating system changes, implementing updated process documents, and supporting user training
• Perform supplier assessments and improve supplier monitoring through improved trending, scorecards, and reports
• Troubleshoot process problems, define root causes, coordinate implementation of corrective actions and verify corrective action effectiveness
• Utilize quality principles and problem solving skills (risk analysis, statistical techniques, etc.) to address product design and manufacturing issues
• Support process and product-related deviation activities including tracking and trending
• Support complaint investigation, recordkeeping and trend reporting
• Review Device History Records (DHRs) and all supporting documentation for accuracy, completeness and compliance
• Work in partnership with supply chain team to ensure supplier qualifications meet current quality standards and regulatory requirements
• Maintain open and effective communication and collaboration with internal and external partners and vendors
• Other tasks as needed to support organizational quality and compliance

Skills and Expertise

• Bachelor’s Degree in engineering related discipline required
• Minimum of 3 years of relevant Quality Management experience in an FDA regulated environment required, ideally within medical device or in vitro diagnostics industry
• ASQ or Six Sigma Certification or equivalent is desired
• Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Design Controls and/or medical device Cybersecurity is required
• Working knowledge of FDA IVD regulations and guidelines and/or experience with FDA and/or notified body audits strongly preferred
• Must be familiar with current Good Manufacturing Practices (cGMP) and other relevant international and FDA regulations
• Experience working with Quality Systems compliant with EN ISO 13485, ISO 14971, IVDR, and 21CFR Part 820
• Demonstrated success achieving results as part of a high performing team and ability to partner effectively throughout the organization to maintain compliance and foster a quality mindset required
• Must be able to read and interpret engineering drawings and component specifications and apply appropriate metrology methods to inspect the components associate with these drawings
• Must be able to interpret an extensive variety of technical instructions in mathematical or diagram form
• Must be familiar with relevant inspection techniques and equipment
• Strong leadership skills with ability to define problems, collect data, establish facts and draw valid statistical conclusions required
• Must have strong technical writing, statistical sampling and data analysis skills; proficient with Microsoft Excel
• Must demonstrate sense of ownership and accountability. Works with a results-oriented approach, a sense of urgency, uses sound judgment and has strong attention to detail
• Must be flexible and able to effectively manage multiple competing priorities. Ability to communicate effectively to multiple levels in the organization and approach tasks with a can-do and positive attitude
• Must have strong desire to foster an environment that encourages teamwork and effective collaboration

About T2 Biosystems