Scientist 2 - Post-Market Investigations

Hologic • San Diego, CA

1d • Onsite

About The Position

We are hiring a highly motivated Scientist 2 in our Diagnostic division, Quality Technical Investigations (QTI) team. In this role and under QA function, you will coordinate and lead high complexity investigations related to customer complaints for assay reagents in Hologic's quality management system and moderate/high complexity projects in support of compliance and overall Hologic continuous improvement efforts. The incumbent will provide Technical Subject Matter Expertise (SME) to all levels of staff including QTI team as well as advising leadership as required. You may be responsible for communicating complex information to the key stake holders for effective decision making. When needed you may be responsible for performing laboratory hands on work to support QTI team’s projects, tasks etc. This is a fully onsite role in San Diego, CA.

Requirements

• Bachelor’s, Master’s or Ph.D. in Chemistry, Biochemistry, Molecular Biology, Biomedical Engineering, or related scientific discipline.
• Experience: 2 - 5 years of industrial experience post-baccalaureate
• 1 - 3 years of industrial experience post M.S
• 1 year of industrial experience post PhD
• Demonstrated expertise in technical investigation, root cause analysis, and scientific problem-solving.
• Experience with complaint investigation, CAPA, and quality systems (FDA, ISO 13485, EU MDR).
• Technical expertise with a strong emphasis on leading projects and investigations is preferred.
• Proficient in laboratory techniques relevant to Hologic’s products (e.g., PCR, immunoassay, analytical chemistry).
• Strong skills in data analysis, statistics, and scientific documentation.
• Strong analytical, critical thinking, and organizational abilities.
• Excellent written and verbal communication skills.
• Ability to work both independently and collaboratively in cross-functional teams.

Nice To Haves

• Experience in the Molecular Diagnostics industry preferably with experience in identifying technical solutions to customer-facing problems associated with IVD products is desirable.
• Understanding of 21 CFR, ISO 13485, ISO 14971 and other regulations relevant to Molecular Diagnostic Industry is desired.
• Experience with manufacturing and design of IVD products is desired.
• Understanding of quality assurance and quality engineering principles such as risk management, investigations and statistical methods is preferable.
• Experience with successful preparation and presentation of high complexity documentation and information across all levels of audience is desired

Responsibilities

• Leads and completes field support activities including addressing inquiries and troubleshooting tasks in a timely manner.
• Leads root cause analysis of high complexity investigations including critical technical review, planning, execution, data analysis, obtaining information, materials and other required support from cross functional teams.
• May execute investigations at customer sites for thorough understanding of the issues relevant to complex and high-risk products based on business needs.
• Authors and/or reviews HHE, PI, ECO/DR, Risk Analysis and other high complexity quality documents as needed.
• Identifies risks, develops mitigation strategies, and ensures project deliverables are achieved.
• Creates and verifies data sets and performs comprehensive analysis using appropriate statistical analysis tools to support customer complaint investigations and process improvements with varying levels of complexity.
• Authors high complexity technical protocols, reports, quality documents, and complaint investigation reports with high quality and relatively less turnaround time.
• Provides technical support during internal and/or third-party audits as needed.
• Leads project(s) to support process improvements and compliance.
• Identifies specific action steps, accountabilities and timelines for completion of project(s) and investigations.
• Manages priorities and secures support from peers, cross functional SME and leadership team.
• Develops short or long-term plans with appropriate contingencies to ensure objectives are met with high probability of success.
• Leads as an SME in efficient trouble shooting and root cause identification based on evidence to address escalated complaints while synthesizing novel ideas.
• Demonstrates leadership in decision making while understanding the implications of decisions for the business.
• Manages junior level team employees.
• Collaborates with cross functional SMEs for successful completion of project(s), investigations etc, lead and execute proactive quality initiatives.
• Collaborates and communicates effectively with junior level employees, peers, cross-functional teams across the organization as needed.
• Represents QTI on a Core Team for a moderate to high complex project.
• Prepares and Present results, issues, progress and other critical information to different audiences including key stakeholders and the leadership team as needed.
• Provide technical guidance and mentorship to junior scientists and quality engineers.
• Share best practices for root cause analysis and technical problem-solving.
• Shows initiative and gains in depth knowledge of existing and new Hologic products, platforms, assay design and chemistries and applies the knowledge for investigations and troubleshooting purposes as needed.
• Continues to gain in depth knowledge of US and OUS quality regulations for IVD products.
• Identifies and implements process improvements to reduce customer complaints and enhance product quality.
• Uses data driven metrics to track and assess the effectiveness of improvements.
• Demonstrates resilience and composure in difficult circumstances.
• Leads additional projects/processes in support of compliance and quality requirements.
• Serves as a mentor on Quality principles to employees across all levels.
• Maintains detailed knowledge of relevant quality system regulations (e.g., 21 CFR Parts 806 and 820, ISO 13485, and ISO 14971).

Benefits

• PTO
• Employee Stock Purchase Plans
• Employee Wellness plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees