Quality Specialist - Product Complaints

Quality Specialist - Product Complaints

San Diego, CA, United States

plays a key role in ensuring the safety, effectiveness, and regulatory compliance of Hologic’s on-market molecular diagnostic products. The ideal candidate will be responsible for monitoring and facilitating the handling of post-market complaints as well as ensuring compliance with applicable industry regulations, standards, and company policy. The role may support product complaint investigations, including lab testing, risk assessment and root cause analysis across Hologic’s global molecular diagnostic product lines.

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Complaint Handling and Investigation:
  Receive, document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR).
• Conduct initial assessments of complaints and work with cross-functional teams as needed to support timely investigation, root cause analysis, and resolution of complaints of moderate complexity.
• Ensure timely, accurate, and complete complaint records in the complaint management system.
• Support product complaint investigations, including lab testing, risk assessment, and root cause analysis 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 KPIs 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, maintaining 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, and train others as needed.

• 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 KPIs 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.

• 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.

• 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.

• 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, complaint handling, and/or complaint trending.
• Prior experience supporting development and/or manufacturing of IVD or other 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.

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