Quality Assurance Lead

Quality Assurance Lead

Drive Medical has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail and e-commerce channels in more than 100 countries around the world.

The Quality Assurance Lead will be responsible for promoting a culture of quality and continuous improvement throughout the organization. This role will be responsible for leading the Quality Management System including regular, cross-functional reporting mechanisms such as QRC, CRB, MRB and others. This role will report to the Senior Director, Quality Assurance.

This position will offer a hybrid work model with 2 days on-site at our Palmetto, Georgia facility.

Main Activities

• 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 SOP 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.

Your Competencies

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

Your Education and Experience

• Bachelor's degree in Life Science, Bioengineering or similar with 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.

Competitive Benefits, Paid Time Off, 401(k) Savings Plan

Pursuant to New York law, Drive Medical provides a salary range in job advertisements. The salary range for this role is $80,000 - $90,000.00 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.

Drive Medical is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants for employment. Drive Medical strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered person because of race, color, religion, gender, sexual orientation, gender identity, pregnancy and/or parental status, national origin, age, disability status, protected veteran status, genetic information (including family medical history), or any other characteristic protected by federal, state, or local law. Drive Medical complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.