Quality Assurance Manager

Zunch Staffing; Nashville (TN); On-site; USD 85,000 - 120,000; Full time

Job summary

Zunch Staffing seeks a Quality Assurance Manager to develop and implement policies for the Quality System in support of custom procedure tray manufacturing, aligned with 21 CFR Part 820 and applicable regulations.

The role focuses on maintaining regulatory compliance with customer and regulatory requirements while fostering a culture of quality across the organization. The manager will lead QA/QC teams and drive continuous improvement in product quality.

Qualifications

• BA/BS in sciences, engineering preferred.
• Minimum 5 years proven experience in the medical device industry.
• Minimum 2 years of supervisory or management experience.

Responsibilities

• Quality Management System oversight and document control in accordance with 21 CFR Part 820.
• Quality reporting, process improvement, and control across production.
• Oversee supplier qualification, internal audits, and CAPA processes.
• Supervise Quality Assurance Technicians and Quality Control Technicians.

Skills

Quality management

Leadership

Regulatory knowledge

Education

BA/BS in sciences, engineering preferred

Job description

Job Description: Quality Assurance Manager

Job Summary: Our client is seeking a Quality Assurance Manager responsible for developing and implementing policies and procedures to support custom procedure tray manufacturing Quality System in accordance with 21 CFR Part 820 and other applicable regulations. This pivotal role focuses on ensuring compliance with customer and regulatory requirements by fostering a strong culture of quality.

Key Responsibilities:

• Quality Management System Oversight: Establish and maintain a Quality Management System compliant with 21 CFR Part 820. Review and approve quality system documents, reports, and records.
• Quality Reporting and Process Improvement: Ensure Quality Records are established and available as per regulations. Implement and oversee Process Controls and Quality Controls throughout the production process.
• Supplier Qualification, Internal Audits, and CAPA Management: Oversee supplier qualification processes. Conduct internal audits and manage Corrective and Preventive Action (CAPA) processes.
• People Management: Supervise and lead Quality Assurance Technicians and Quality Control Technicians.

Qualifications:

• Education: BA/BS in sciences, engineering preferred.
• Experience: Minimum 5 years proven experience in the medical device industry. Minimum 2 years of experience in a supervisory or management role.

Additional Information:

• Reports to: Executive Director Quality and Regulatory.
• Full-Time Employees (FTE's): 9.
• Top 3 Objectives:
  • Ensure ongoing compliance with FDA requirements while optimizing the quality system and transitioning to ISO 13485.
  • Collaborate with Operations to reduce in-process defects, customer complaints, and recalls, ensuring high-quality product delivery.
  • Develop a strong culture of Quality across all departments, facilitating and supporting growth.
• Reason for Vacancy: New Position
• Must-Have Attributes:
  • Ability to collaborate across departments.
  • Friendly and professional demeanor.
  • Capability to make decisions that may impact Operations or Financials.

Our client is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.