Quality Specialist - Product Complaint Investigation and Analysis

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Quality Specialist - Product Complaint Investigation and Analysis

San Diego, CA, United States

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The Post-Market QA Specialist plays a key role in ensuring the safety, effectiveness, and regulatory compliance of Hologic's on-market molecular diagnostic products. The ideal candidate will independently handle all aspects of post-market complaints under the guidance of product subject matter experts and quality leadership, from intake of complaints from customer service teams to complaint monitoring / trending and root cause investigation. The QA Specialist monitors and analyzes complaint data for adverse trends. The QA Specialist then works hands-on in laboratory with Hologic's molecular diagnostic products to investigate safety impact and root cause of these trends. This role facilitates the documentation of activities throughout the complaint handling process incompliance with applicable industry regulations, standards, and company policy.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Complaint Handling, receive, document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR).
• Ensure timely, accurate, and complete complaint records in the complaint management system
• Complaint Investigation
• Plan and execute testing and / or inspection of Hologic molecular diagnostic products
• Analyze testing data/product information to assess and document complaint risk in accordance with ISO14971 and QMS requirements
• Collect, analyze, and / or present test results or other data in cross-functional presentations, reports, or quality system documentation
• Support management of equipment, inventory, product testing in the Quality Technical Investigation laboratory as needed
• Regulatory Reporting
• Identify and escalate potential adverse events to QA management.
• Support preparation and submission of regulatory reports (e.g., FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory requirements
• Ensure post-market activities are compliant with Hologic's quality system and all applicable standards
• Data Analysis & Trending
• 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
• Audit & Inspection Support:
• Support internal and external audits related to post-market surveillance and complaint handling as needed
• Maintain accurate and audit-ready documentation.
• Training & Process Development, contribute to the development and improvement of processes, SOPs, work instructions, and training materials related to post-market quality assurance

KNOWLEDGE

• Quality Systems: Working knowledge of post-market surveillance, complaint handling, risk management, and non-conformance / CAPA processes
• Compliance: Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and global post-market surveillance requirements
• Data Trending: Basic knowledge of tracking and trending product / process metrics and KPI's with statistical methods and data visualization tools (e.g., Power BI), ideally for manufacturing or technical support of high-volume products
• Product Knowledge: 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

SKILLS

• Communication: aptitude to clearly explain data, processes, compliance requirements to cross-functional audiences in meetings, presentations, and reports
• Organization: skilled at planning, executing, and managing tasks and processes to drive action individually and with others in a team setting
• Data Analysis: aptitude to compile, research, and critically evaluate data to identify and understand patterns / trends as well as make informed conclusions

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
• Resourceful: applies self-directed research, problem solving, critical thinking, collaboration skills to approach uncertainty and adapt to change
• Customer Focused: commitment to understanding and championing customer needs and promoting excellent customer experience with Hologic products

REQUIREMENTS

• B.S. in scientific or engineering discipline
• 3+ years of experience in a quality role within an ISO 13485 quality management system, ideally with focus on Post-Market Surveillance, technical support, clinical lab experience, complaint handling, and / or complaint trending of IVD and / or medical device products
• Prior experience understanding customer issues, championing customer needs, and improving customer experience with IVD or medical device products preferred.

The annualized base salary range for this role is $71,000 - $104,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

If you have the right skills and experience, apply today!

#LI-AV1

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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