Quality Engineer, Technical Investigation San Diego, CA, United States 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. We are hiring an experienced Quality Engineer in our Diagnostics division here in San Diego. In this role and under our QA function's Quality Technical Investigation (QTI) team, you will drive various QA activities and processes including but not limited to investigations, from issue identification to implementation of solutions, and verification of effectiveness. In this role, you will manage all aspects of applicable processes and activities, which include aligning with cross functional stakeholders, facilitating team meetings, and ensuring deliverables per project timelines, and maintaining and reporting on the process to leadership. This is a fully onsite role in San Diego, CA. **Essential Duties and Responsibilities** + Investigations (CAPA, NCEs Complaints) + Responsible for identification of quality issues, including defects and deviations from standards and specifications. + Applies various investigative approaches for efficient root-cause determination. + Develops optimal solutions to address identified issues and implements them effectively to prevent recurrence. + Monitors and measures the effectiveness of the implemented solutions using relevant metrics. + Establishes plans to proactively prevent future quality issues. + Maintains detailed records of investigations, actions taken, and their effectiveness with accuracy, completeness and clarity. + Supports investigation activities during audits and appropriate Review Board meetings as needed. + Leadership and Collaboration + Leads investigations with ownership by applying project management principles to planning, investigating, executing, measuring and closing in a cross functional environment. + Works with cross-functional teams (OPS, QC, QA, R&D, RA and others) to implement and monitor effectiveness of solutions. + Fosters partnerships, communicating effectively with interdepartmental teams and stakeholders to develop and implement quality plans, procedures, and protocols. + Provides guidance to others on documenting investigation activities such as investigation plans, reports and risk assessments. + Collaborates with internal partners to maintain relationships and communicates quality expectations. + Provides status updates to appropriate personnel at all levels, including management, peers, and key stakeholders. + Continuous Improvement + Shows initiative, participates and contributes to a culture of continuous improvement through process and product improvement activities. + Identifies risks and gaps, develops mitigation strategies and ensures that the mitigations are implemented effectively. + Collects input from internal stakeholders and conducts statistical analysis of quality data to identify and implement continuous improvement projects and solutions that are sustainable and drive value for the business. + Uses data driven metrics to track and assess the effectiveness of improvements. + Additional Responsibilities: + Leads additional projects/processes in support of compliance and quality requirements. + Understands technical aspects of products by collaborating with relevant SMEs. + 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). **Required Education and Experience:** + Quality experience with a strong emphasis in Quality Systems, Risk Management, Root Cause Analysis and CAPA is preferred. + Ph.D or Master's in life sciences, chemical sciences, bioengineering highly preferred, with at least 2 - 5 years of quality experience in an industry setting is desirable. + Experience with Regulatory Inspections is desirable. + Advanced understanding of 21 CFR Part 806, 820, ISO 14971 and ISO 13485. + Advanced understanding of quality assurance and quality engineering principles including risk management, nonconformance and CAPA, root cause investigation, trend analysis, statistical methods, and acceptance sampling. + Experience with manufacturing and design of IVD products is desired. + Must be capable of providing presentations across all levels. + Demonstrated successful preparation and presentation of documentation and information for audits and inspections. **So why join Hologic?** We are committed to making Hologic the company where top talent comes to grow and giving you the tools and knowledge you need to succeed in your role. From a benefits perspective, you will join our wide-ranging benefits policy including PTO, Employee Stock Purchase Plans, exciting Employee Wellness plans and many more. The annualized base salary range for this role is $95,800 - $149,900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. **_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.** \#LI-RF1 #onsite