Quality Assurance Manager for Medical Devices
hace 1 mes
Overview
We are a global healthcare company with a rich history of innovation and pioneering. Our mission is to improve the health and wellbeing of people around the world.
About the Role
This is an exciting opportunity to join our team as a Quality Assurance Manager for Medical Devices. In this role, you will be responsible for ensuring that our products meet the highest standards of quality and safety.
Responsibilities
- Provide technical expertise to support product and process improvements.
- Contribute to project teams, such as R&D, CAPA, and coordinate protocols, Engineering studies and/or pilot processes as required.
- Ensure that the New Product Development (NPD) process is transferred in a timely manner as it relates to the creation of Action Copies (ACs), investigation plans, and the execution of the protocol.
- Review and approve AC and investigation plan change requests for your assigned franchise.
- Collaborate with the CAPA franchise for the product families assigned.
- Have knowledge of all quality-related aspects pertaining to complaints for the assigned franchise (CAPAs, NCRs, etc.).
- Participate in Rapid Response teams for product families assigned.
- Assist in training engineers and technicians to complaint investigation process.
- Comply with company safety policies and procedures.
Requirements
- Bachelor of Science in Engineering or relevant experience.
- ASQ Quality Engineering Certification preferred.
- 4-6 years with BS in related field, 5+ years with MS, 1+ year with PhD.
- Approximate experience within a regulated medical device environment.
- Complaint handling experience recommended.
- Bilingual: English/Spanish required.
- QSR/ISO knowledge preferred.
- Technical writing skills for Customer Letters required.
- Knowledge of risk management required.
- Failure investigation tools knowledge preferred.
- Strong Communications skills required.
- Analytical skills required.
- Medical device product knowledge preferred.
- Product Complaint experience preferred.
- Statistical Analysis Software.
- Knowledge of EES information systems such as Electronic Complaint system, AQR, NC, CAPA, Audit and ERP preferred.
Estimated Salary Range: $90,000 - $120,000 per year
Location: Juarez, Chih., Mexico
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