Sr. Manager, Quality Compliance

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. The Senior Manager, Quality Compliance, provides operational leadership for Quality Compliance activities at Healthmark Industries within the Surgical Workflows – Infection Control Consumables (SWICC) business, ensuring regulatory and quality system compliance for U.S. FDA Class I and II medical devices, EU MDR Class I and Class IIa/IIb devices, and similarly classified products globally.

Requirements

• Develops and manages the department to assess and ensure compliance with applicable regulations and standards
• Maintains the Quality Management System, Internal Audit program, and other processes
• Leads the quality compliance team and coordinates activities to effectively maintain the quality system
• Provides Quality review and approval for change notices, ensuring compliance with applicable regulatory requirements, quality system procedures, and change control processes
• Leads and manages all external regulatory inspections and third-party audits
• Maintains compliance with 21 CFR 820, 803, 806, ISO 13485, ISO14971, and other applicable standards

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement