Scientist – Post-Market Quality Technical Investigation (IVD)

Job title: Scientist – Post-Market Quality Technical Investigation (IVD)

Company: Hologic


Job description: Job Description:Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.The San Diego Campus is the center of our Diagnostics Solutions Division. With the focus on Molecular Diagnostics, most products produced are utilized onboard innovative and fully automated sample-to-result instrument systems. The consumables required for patient testing are integral to our business. The business growth projections and new product development projects provide unique opportunities to enable our Purpose, Passion, and Promise to empower global health advancements.Our Quality Assurance department is looking for a Scientist to join our Quality Technical Investigation (QTI) team to support the technical resolution of Hologic Diagnostics customer complaints. The role entails planning and executing experimental work and projects to accomplish project goals, performing moderate to complex risk assessments and leading customer complaint investigations.This is a fully onsite position in San Diego, CA.The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.Key Responsibilities:

• Conduct Research and Testing:

• Design, plan, and execute scientific experiments and research studies in alignment with project goals.
• Develop and optimize experimental protocols and methodologies.
• Data Collection and Analysis:

• Collect, record, and analyze experimental data accurately and efficiently.
• Utilize various analytical tools and software to interpret data and draw meaningful conclusions.
• Report Writing:
• Author technical protocols, technical reports, and complaint investigation reports.
• Document experimental procedures, results, and analyses in lab notebooks and databases.
• Collaboration:

• Collaborate with cross-functional teams to achieve project objectives, including other scientists, engineers, and project managers.
• Participate in team meetings, providing updates on investigation progress and contributing to problem-solving discussions.
• Continuous Learning and Continuous improvement:

• Stay current with advancements in scientific research, technologies, and industry trends.
• Attend conferences, workshops, and training sessions to enhance knowledge and skills.
• Participate in continuous improvement initiatives to enhance product quality, reduce defects, and improve overall efficiency by demonstrating and promoting a culture of continuous improvement by utilizing LEAN and Six Sigma methodologies

Required Education and Experience:

• Ph.D or M.S in Molecular Biology, Microbiology, Chemistry, Biochemistry or Bioengineering/Biomedical Engineering with at least 2 – 4 years of relevant industry experience, preferably in the IVD or pharmaceutical space
• Good knowledge of microbiology, molecular biology, biochemistry, chemistry and/or related disciplines
• Good understanding of nucleic acid amplification and detection technologies
• Good understanding of Scientific Method and statistical analysis
• Ability to plan and supervise execution of projects, keep to timelines and prioritize resources
• Ability to troubleshoot and solve technical issues across multiple assays and platforms
• Ability to analyze data and come to valid scientific conclusions
• Ability to document technical work and lead investigations and improvements in a GMP environment
• Good technical writing skills and ability to prepare and present data
• Ability to work collaboratively with intra- and inter-departmental teams.
• Working knowledge of FDA and ISO regulations that govern the Medical Device and Molecular Diagnostic Industry a plus

The annualized base salary range for this role is $84,100 to $131,600 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-RF1 #Mid-levelAgency 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.

Expected salary: $84100 – 131600 per year

Location: San Diego, CA

Job date: Sun, 26 Jan 2025 05:48:13 GMT

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