Summary: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 is
on-site, and will sit inside a Distribution Center Warehouse 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.
Why Apply to Drive Medical...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.
