Quality Assurance Lead

About the role

Drive Medical is a leading manufacturer of medical products with a strong and consistent track record of growth. Our products are sold into the homecare, long-term care, retail, and e-commerce channels in more than 100 countries worldwide. This position is on-site within a Distribution Center Warehouse facility and reports to the Senior Director, Quality Assurance.

Responsibilities

• Promote a culture of quality and continuous improvement throughout the organization.
• Lead the Quality Management System, including regular, cross-functional reporting mechanisms such as QRC, CRB, MRB, and others.
• Establish and evolve quality metrics monitoring, trending, response, and promotion to corrective actions as appropriate.
• Develop, implement, and improve SOPs for continued compliance and product iterations.
• Review documentation to ensure appropriate risk assessment, action plan, and effectiveness of implementations.
• Ensure site readiness for external audits and inspections.
• Support and participate in external audits and inspections as appropriate.
• Review training curricula for applicability, completeness, and strength of program.
• Perform tasks in accordance with GMP and other applicable regulations, standards, and requirements.

Duties, responsibilities, and activities may change at any time with or without notice.

Requirements

• Bachelor's degree in Life Science, Bioengineering, or a similar field.
• 3-5 years of experience working in a manufacturing environment.
• Understanding of product development, manufacturing, quality, and servicing in the medical device or pharmaceutical industry.
• Experience with medical devices preferred.

Skills

• Team mindset
• Excellent communication abilities
• Strong analytical skills
• Critical thinker
• Creative problem-solving capabilities
• Detailed-oriented and able to perform in high-pressure environments

Benefits

• Competitive benefits
• Paid Time Off
• 401(k) Savings Plan

Pay

The salary range for this role is $80,000 - $90,000 per year. Actual salaries may vary depending on factors such as the applicant’s experience, specialization, education, as well as the company’s requirements. The provided salary range does not include bonuses, incentives, differential pay, or other forms of compensation or benefits which may be offered to the applicant, if eligible according to the company’s policies.