Sr Manager, Quality Engineering & Risk Management

Hologic is an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day!As a Senior Manager, Quality Engineering and Risk Management within Hologic’s Diagnostics division in San Diego, you’ll step into a high-impact, highly visible leadership role where you get to build, shape, and elevate how you and your team drive Quality in New Product Development.Managing the Design Assurance, and Risk Management teams, you will direct us in further strengthening the quality, safety, and reliability of our diagnostic solutions around the world. This is an exciting opportunity to architect and grow two pivotal functions right at the heart of an innovation-driven, mission-focused organization. You’ll define the vision, strategy, and roadmap for how Quality and Risk are embedded from concept through commercialization, ensuring our diagnostics are not only compliant, but truly best-in-class in performance and patient impact. If you’re excited by the idea of building and inspiring teams, influencing cross-functional leaders, and making Quality a strategic driver of product success, read on below.This is a fully on-site position in San Diego, CA.Design Assurance team: responsible for supporting design control activities as members of product development core teams ensuring design control systems and processes are compliant with all applicable standards and regulations, ensuring post-market feedback information feeds into the design control process, and ensuring products are transferred successfully to the manufacturing teams. Risk Management team: responsible for generating and maintaining risk documents, such as product risk assessments, fault-tree analysis, hazard analysis, safety risk analysis, and Design Failure Mode Effect Analysis (DFMEA). These risk documents support the products developed and manufactured at Hologic San Diego throughout the entire product lifecycle. These risk documents support the products developed and manufactured at Hologic San Diego throughout the entire product lifecycle. Essential Duties And ResponsibilitiesResponsible for strategic workforce planning, developing and implementing employee communication and training programs in connection with Hologic quality objectives, strategies, and processes Provide guidance and direction to the teams to ensure clear understanding of job responsibilities, task objectives, deadlines, and performance expectationsManage team priorities and workloadDetermine how to improve coordination, productivity and the effectiveness of the teamsDevelop and monitor team goalsResponsible for ensuring risks and updates for projects are clearly and regularly communicated to senior management and support teamsDevelop, maintain and report department metrics Gather information about work activities and external conditions affecting the workCheck on the progress of and quality of the workMonitor and manage on-market data (non-conformances, complaints, deviations, etc.) to drive improvements in design control and risk management Develop recommendations based on data analyses and ensure corrective actions are appropriate to the risk levelAdvocates strategically and operationally effective solutions to complex problemsManage team activities to ensure the Quality Engineering deliverables are completed on time and with a high degree of qualityMeet regularly with employees to discuss updates, development, escalation, or other topics in a formal settingConduct employees’ performance appraisals Identifies resource needs and facilitates allocation of resources, resolution of resource conflicts, and business justifications and trade-offs related to resource utilizationAssists with the resolution of non-conformances and complaints generated within the early launch periodEnsure design history files are complete and accurateDrive changes in design control as required by the changing regulatory environmentEvaluate adequacy of all deliverables required during the product development processRepresent Quality in reliability programs and projectsMember of Post Launch Surveillance TeamManage the REACH compliance programManage the team responsible for developing and maintaining product risk analysis documentation Manage the team responsible for assessing the quality and validation impact on change orders, ECOs, SCOs and ECRs Grow talent within the organization by leading employee development initiatives to create a high-impact team to execute tactical and strategic imperative Provides quality support and content for regulatory submissionsDevelop and manage Quality Engineering standard operating proceduresProvide design assurance and risk management support to other Diagnostic Solutions sitesRepresent QE on cross-functional project teams Ability to complete product risk assessments, fault-tree analysis, hazard analysis, safety risk analysis, and Design Failure Mode Effect Analysis (DFMEA) to lead a risk discussion with a clinician and product subject matter expertProvide technical support (subject matter expert) during audits (internal and third-party)Assist in suppliers audit as subject matter expertEffectively manage cross-functional relationships and establish clear roles and responsibilities to drive accountabilityDrive continuous improvement initiatives to enhance product quality, reduce defects, and improve overall efficiency. Demonstrate and promote a culture of continuous improvement by utilizing LEAN and Six Sigma methodologies.Remain current on FDA, ISO and other regulatory requirements and standardsRepresent QE by participating in design reviewsRepresent QE by participating in Material Review Board (MRB) meetingsProvide praise and recognition for effective performance, significant achievements, and special contributionsRequired Qualifications And ExperienceRequires a BS and 12 years related experience or MS and 10 years, or PhD and 8-10 years related experience in a scientific discipline or equivalent in engineering.Experience in in-vitro diagnostic, medical device, biotech, or pharmaceutical industry.Strong execution knowledge of QMS systems, FDA regulations, ISO 13485, MDD / IVDD / IVDR / MDR/ ISO14971Strong background in root cause analysis, risk management, FMEA, design control, change control, validation, CAPA management, and continuous improvement methodologiesDemonstrated change management experience, guiding the organization to the desired stateExcellent analytical and problem-solving skillsStrong leadership and team management abilitiesProficient in a variety of validation methods and evaluation criteriaAttention to detail and a solid commitment to maintaining high-quality standardsEnterprise mindset that can break down silos. Ability to bring people together to work towards the same purpose across organization boundaries. Track record in leading teams directly or indirectly in multicultural and matrix environments.Good understanding of engineering drawings and symbolsExperience with FDA and other regulatory agency interactionsExperience with risk management process and documentationExperience with electronic document management systemsGood understanding of statistics, SPC and acceptance samplingIn depth knowledge of QSR, CDRH, ISO regulations (13485 and 14971), IVDR, IEC 62304, MDSAP, and MDRAdvance knowledge of 21 CFR Part 11 Excellent communication skills (written, verbal, and presentation)Advanced computer skillsAbility to multi-task effectively, execute to aggressive timelinesAdaptable to fast-paced, dynamic work environments with shifting demandsThe annualized base salary range for this role is $147,000 to $245,000 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!#SrManager-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.