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Senior Quality Assurance Engineer

5 months ago

Lexington, United States T2 Biosystems Full time
Job DescriptionJob DescriptionDescriptionWe are seeking a bright, energetic and detail-oriented individual to join our team as a Senior Quality Assurance Engineer. This is an exciting role that will serve as the quality partner for our engineering and instrument manufacturing teams and will be responsible for promoting product quality and quality system compliance across those areas. The position reports directly to the Vice President, Quality and Regulatory Affairs.

The ideal candidate will be someone that enjoys working as part of a fast paced, cross-functional team and leads by example with a positive, can-do attitude.  This individual must be able to partner with team members at all levels of the organization.  

In addition to those skills and attributes, we’re looking for someone that thrives in a rapidly growing environment and is interested in developing and advancing their career along with the organization. 
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