Quality Engineer 2 - Post Market Surveillance and Investigation

Hologic • San Diego, CA

1d • $79,000 - $124,800

About The Position

This Quality Engineer role monitors the quality and safety of Hologic’s on-market molecular diagnostic products. This role will build and sustain processes and tools to monitor product performance, monitor product risk, trend complaint / field data, and support risk assessment of on-market issues / trends. This role additionally applies technical expertise with in vitro diagnostic reagents / systems, data analysis, and root cause analysis methods to address product issues as well as support continuous improvement across Hologic’s global molecular diagnostic product lines. Essential Duties and Responsibilities The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Work hands-on to implement state-of-the-art complaint and adverse event trending metrics and methods, including definition / optimization of complaint trending codes, analysis methods, and trending action limits Sustain routine monitoring and trending of product performance, complaint data, adverse event reporting data, and quality KPI’s to identify and track potential product issues Create, sustain, and analyze dashboards to track and trend product and process performance Conduct statistical analysis of complaint / field trending data to identify and track potential product issues and opportunities for continuous improvement Present tracking / trending of complaint / field data in cross-functional meetings, reports, and quality system documentation Support product complaint investigations, including lab testing, risk assessment, and root cause analysis Provide technical leadership and subject matter expertise to support field actions, non-conformance / CAPA initiatives, and adverse event reporting Collaborate with other functional areas to harmonize field / complaint data and risk assessments with product risk management files Support initiatives to maintain environment of continuous improvement and compliance Knowledge Quality Assurance Compliance: General knowledge of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and global post-market surveillance requirements. Quality Systems: Working knowledge of complaint handling, risk management, Non-conformance / CAPA processes Risk Management: Proficiency with ISO 14971 risk management practices and tools, (e.g., FMEA, hazard analysis, fault tree analysis) Data Analysis Data Analysis Methods: Advanced knowledge of tracking and trending product / process metrics and KPI’s, ideally for manufacturing or technical support of high volume products Statistical Analysis: Expertise applying statistical analysis, six sigma / lean to large datasets Data Analysis Tools: Knowledge of data systems and tools for analyzing large sets of product data (e.g., Oracle, Agile/PLM, PowerBI) Technical Product Expertise: Familiarity with processes and practices related to the design and manufacturing of in vitro diagnostic or medical device products, ideally with high volume automated reagent / hardware systems Root Cause Analysis: Expertise applying root cause analysis methodologies (e.g., 6M, 5 Whys, Fishbone diagrams) to address complex technical problems Skills Data Analysis: Aptitude to compile, research, and critically evaluate data to identify and understand patterns / trends as well as make informed conclusions and decisions Investigation: Able to apply critical thinking, technical expertise, and root cause analysis tools to develop understanding of underlying causes of patterns, trends, and problems based on data / facts. Communication: Skilled at translating complex technical information from data analyses / investigations into clear and accurate reports and presentations that support communication with cross-functional audiences and regulatory authorities. Behaviors Detail Oriented: Proactively identifies and focuses on critical details needed to ensure accurate and high-quality results Inquisitive: Strong intellectual desire to understand and address technical issues by seeking information through asking probing questions, research, data analysis, and collaboration with others Quality / Safety Focused: Committed to ensuring product quality and safety by making and documenting objective conclusions based on data and facts

Requirements

• B.S. in scientific or engineering discipline; Advanced degree and / or CQE certification preferred
• 3+ years of experience in a quality role within an ISO 13485 quality management system, ideally with focus on Post-Market Surveillance, complaint handling, and / or complaint trending.
• Proven experience conducting root cause investigation and statistical analysis of quality data (e.g., KPI’s, trend analysis, reliability) for medical device products
• Prior experience supporting development and / or manufacturing of IVD or other medical device products
• General knowledge of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and global post-market surveillance requirements.
• Working knowledge of complaint handling, risk management, Non-conformance / CAPA processes
• Proficiency with ISO 14971 risk management practices and tools, (e.g., FMEA, hazard analysis, fault tree analysis)
• Advanced knowledge of tracking and trending product / process metrics and KPI’s, ideally for manufacturing or technical support of high volume products
• Expertise applying statistical analysis, six sigma / lean to large datasets
• Knowledge of data systems and tools for analyzing large sets of product data (e.g., Oracle, Agile/PLM, PowerBI)
• Familiarity with processes and practices related to the design and manufacturing of in vitro diagnostic or medical device products, ideally with high volume automated reagent / hardware systems
• Expertise applying root cause analysis methodologies (e.g., 6M, 5 Whys, Fishbone diagrams) to address complex technical problems
• Aptitude to compile, research, and critically evaluate data to identify and understand patterns / trends as well as make informed conclusions and decisions
• Able to apply critical thinking, technical expertise, and root cause analysis tools to develop understanding of underlying causes of patterns, trends, and problems based on data / facts.
• Skilled at translating complex technical information from data analyses / investigations into clear and accurate reports and presentations that support communication with cross-functional audiences and regulatory authorities.
• Proactively identifies and focuses on critical details needed to ensure accurate and high-quality results
• Strong intellectual desire to understand and address technical issues by seeking information through asking probing questions, research, data analysis, and collaboration with others
• Committed to ensuring product quality and safety by making and documenting objective conclusions based on data and facts

Nice To Haves

• Advanced degree and / or CQE certification

Responsibilities

• Work hands-on to implement state-of-the-art complaint and adverse event trending metrics and methods, including definition / optimization of complaint trending codes, analysis methods, and trending action limits
• Sustain routine monitoring and trending of product performance, complaint data, adverse event reporting data, and quality KPI’s to identify and track potential product issues
• Create, sustain, and analyze dashboards to track and trend product and process performance
• Conduct statistical analysis of complaint / field trending data to identify and track potential product issues and opportunities for continuous improvement
• Present tracking / trending of complaint / field data in cross-functional meetings, reports, and quality system documentation
• Support product complaint investigations, including lab testing, risk assessment, and root cause analysis
• Provide technical leadership and subject matter expertise to support field actions, non-conformance / CAPA initiatives, and adverse event reporting
• Collaborate with other functional areas to harmonize field / complaint data and risk assessments with product risk management files
• Support initiatives to maintain environment of continuous improvement and compliance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees