Sr Manager, Quality Engineering & Risk Management

Hologic•San Diego, CA

6h•$147,000 - $245,000•Onsite

About The Position

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.

Requirements

Requires 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/ ISO14971
Strong background in root cause analysis, risk management, FMEA, design control, change control, validation, CAPA management, and continuous improvement methodologies
Demonstrated change management experience, guiding the organization to the desired state
Excellent analytical and problem-solving skills
Strong leadership and team management abilities
Proficient in a variety of validation methods and evaluation criteria
Attention to detail and a solid commitment to maintaining high-quality standards
Enterprise 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 symbols
Experience with FDA and other regulatory agency interactions
Experience with risk management process and documentation
Experience with electronic document management systems
Good understanding of statistics, SPC and acceptance sampling
In depth knowledge of QSR, CDRH, ISO regulations (13485 and 14971), IVDR, IEC 62304, MDSAP, and MDR
Advance knowledge of 21 CFR Part 11
Excellent communication skills (written, verbal, and presentation)
Advanced computer skills
Ability to multi-task effectively, execute to aggressive timelines
Adaptable to fast-paced, dynamic work environments with shifting demands

Responsibilities

Responsible 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 expectations
Manage team priorities and workload
Determine how to improve coordination, productivity and the effectiveness of the teams
Develop and monitor team goals
Responsible for ensuring risks and updates for projects are clearly and regularly communicated to senior management and support teams
Develop, maintain and report department metrics
Gather information about work activities and external conditions affecting the work
Check on the progress of and quality of the work
Monitor 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 level
Advocates strategically and operationally effective solutions to complex problems
Manage team activities to ensure the Quality Engineering deliverables are completed on time and with a high degree of quality
Meet regularly with employees to discuss updates, development, escalation, or other topics in a formal setting
Conduct employees’ performance appraisals
Identifies resource needs and facilitates allocation of resources, resolution of resource conflicts, and business justifications and trade-offs related to resource utilization
Assists with the resolution of non-conformances and complaints generated within the early launch period
Ensure design history files are complete and accurate
Drive changes in design control as required by the changing regulatory environment
Evaluate adequacy of all deliverables required during the product development process
Represent Quality in reliability programs and projects
Member of Post Launch Surveillance Team
Manage the REACH compliance program
Manage 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 submissions
Develop and manage Quality Engineering standard operating procedures
Provide design assurance and risk management support to other Diagnostic Solutions sites
Represent 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 expert
Provide technical support (subject matter expert) during audits (internal and third-party)
Assist in suppliers audit as subject matter expert
Effectively manage cross-functional relationships and establish clear roles and responsibilities to drive accountability
Drive 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 standards
Represent QE by participating in design reviews
Represent QE by participating in Material Review Board (MRB) meetings
Provide praise and recognition for effective performance, significant achievements, and special contributions