Role OverviewThe Senior Quality Systems Manager provides strategic leadership for the Quality Management System (QMS), ensuring its effectiveness, regulatory compliance, and continuous improvement. This role is accountable for overseeing the Corrective and Preventive Action (CAPA) program and key quality system processes, including quality planning, management review, quality metrics, training, change control, and enterprise quality initiatives.
What You Will Do
Provide strategic and operational leadership for the Quality Management System (QMS) and continuous improvement initiatives. Lead the governance and oversight of the CAPA program, ensuring timely execution, effectiveness, and regulatory compliance. Oversee core quality system processes, including change control, training, management review, quality planning, and quality metrics.
Why It Might Be a Fit
Must have a strong understanding of global regulatory requirements for medical devices, including FDA Quality Management System Regulation (QMSR), ISO 13485, and European Medical Device Regulation. Excellent written and verbal communication skills, with the ability to influence stakeholders and communicate effectively across all levels of the organization.
Requirements
- Bachelor’s degree required with a minimum of 7 years in Quality Systems within the medical device industry with 5+ years of people management experience.
- OR advance degree with a minimum of 5 years in Quality Systems within the medical device industry with 5+ years of people management experience.
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
- Simple Steps (global well-being program)
- 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 (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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