Key skills
LeadershipRisk ManagementCommunication
About this role
Role Overview
- Acts as the Quality Core Team Member (QCTM) and program‑level Quality lead for assigned product development programs
- Plans, directs, and oversees all Quality aspects of design and development
- Leads and integrates Quality program planning
- Provides Quality leadership for design verification and validation activities
- Ensures robust test method development, qualification, and validation
- Owns and drives product and process risk management activities
- Leads Quality oversight for design transfer
- Guides cross‑functional teams through phase gate reviews
- Monitors and ensures the integrity of design history file (DHF) documentation
- Coordinates Quality activities with external suppliers, test labs, and consultants
- Identifies gaps, risks, and improvement opportunities within Quality processes.
- Is a mentor, leader or direct manager to earlier career QCTMs
Requirements
- Bachelor's degree and a minimum of 7 years of relevant experience OR an advanced degree with a minimum of 5 years of relevant experience
- Experience working with Class III medical devices
- Broad knowledge of Quality systems and product development
- Proven experience leading cross‑functional, matrixed teams on complex product development programs
- Strong understanding of design controls, design verification and validation, risk management, test methods, and design transfer.
- Physical demands: independently mobile, computer interaction, peer communication.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan