Sr Manager, Quality Engineering & Risk Management

Hologic is an innovative medical technology company seeking a Senior Manager, Quality Engineering & Risk Management to lead the Design Assurance and Risk Management teams in San Diego, CA. This role will drive quality, safety, and reliability of diagnostic solutions worldwide, building and inspiring teams, influencing cross-functional leaders, and making Quality a strategic driver of product success.

Requirements

• Strategic workforce planning
• Employee communication and training programs
• Guidance and direction to teams
• Team priorities and workload management
• Risk and update communication to senior management
• Department metrics development and monitoring
• On-market data monitoring and management
• Corrective action development and implementation
• Team activities management
• Performance appraisals
• Resource allocation and conflict resolution
• Non-conformances and complaints resolution
• Design history file maintenance
• Change control in design control
• Deliverable evaluation
• Quality representation in reliability programs
• Post launch surveillance team membership
• REACH compliance program management
• Product risk analysis documentation management
• Change order assessment and validation impact
• Quality support for regulatory submissions
• Quality Engineering standard operating procedures development and management
• Design assurance and risk management support to other Diagnostic Solutions sites
• Cross-functional project team representation
• Risk discussion with clinician and product subject matter expert
• Audit support as subject matter expert
• Supplier audit as subject matter expert
• Continuous improvement initiatives
• LEAN and Six Sigma methodologies
• Regulatory requirement knowledge
• Design review participation
• Material Review Board meetings participation
• Performance recognition

Benefits

• Annualized base salary range of $147,000 to $245,000
• Bonus eligibility
• Comprehensive training
• Continued development and training
• Equal Opportunity Employer inclusive of disability and veterans