Quality Assurance Engineer - Lexington, United States - T2 Biosystems

T2 Biosystems Lexington, United States

2 weeks ago

Description

We are seeking a bright, energetic and detail-oriented individual to join our team as a Quality Assurance Engineer.

This is an exciting role that will serve as the primary quality partner for our instrument manufacturing operations and is responsible for promoting product quality and quality system compliance across those areas.

The position reports directly to the Manager, Quality Assurance.

The ideal candidate will be someone that enjoys working as part of a fast paced, cross-functional team, balancing multiple tasks and focused on achieving results.

They will lead by example with a positive, can-do attitude and will apply their critical thinking skills when getting things done.

This individual must be able to communicate with team members at all levels and be comfortable both challenging and influencing others and being challenged by others without getting defensive.

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.
Conduct internal audits and support timely completion of audit findings.
Work with teams to define and develop action plans and support timely closure of Corrective and Preventative Actions (CAPA).

Generate quality reports that track cycle times, yields/quality rates, and evaluate trends through Pareto charts for various quality system and product performance metrics.

Develop IQ, OQ and PQ protocols for measurement, test, quality system and instrument manufacturing equipment/software; execute protocols and generate reports as necessary.

Perform supplier assessments and improve supplier monitoring through improved trending, scorecards, and reports.
Disposition, process, and track non-conforming material reports (NCMRs).
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 positive and effective communication and collaboration with all levels of the team and our outside 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 5 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 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, IVDD, 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 team work and effective collaboration.

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