Senior Quality Assurance Manger

About the job

YOUR PURPOSE

The Senior Quality Assurance Manager position will be responsible for management oversight and enhancement of the Complaint Handling, CAPA, Calibration, Preventive Maintenance, Training, Document Control and Internal Audit programs.

YOUR RESPONSIBILITIES

Responsible for the Complaint Handling System including leading the Designated Complaint Handling Unit and hosting Complaint Board Meetings. This includes processing or overseeing incoming customer feedback and complaints, handling images, returned devices, tissue processing and other information related to the investigation of complaints. Responsible for the CAPA system including leading the CAPA Board Meetings. This includes initiating, reviewing, approving, and closing CAPAs. Maintain the NetSuite and eQMS databases. Coordinate with EU Regulatory Consultant on reportable events related to devices marketed in the UK or Europe, including preparing reports and responses, trending data and providing DHR review, etc. Oversee Cal/PM activities and administration of external standards including maintaining the Cal/PM listing and ensuring instrument and equipment are reviewed as per their schedule. Work with operations and R&D to ensure new instruments or equipment are properly entered into the system as well as obsoleting no longer used instruments or equipment. Manage and host internal and external audits. Assist in preparing Management Review Presentations, hand‑outs, and supporting documentation for areas of responsibility. Support other department system activities, including trend analysis, verification and supplier quality administration. Perform DHR review or risk management file review to support the quality management system. Initiate system and process enhancements to ensure department efficiency and customer satisfaction. Administration of Moximed's eQMS systems and support the development and implementation of additional electronic Quality System modules when requested. Lead or oversee complaint handling training for all employees. Write and coordinate efforts for the development and implementation of new and updated Quality System procedures. Perform other quality systems assignments and projects as assigned.

OUR REQUIREMENTS:

Education and Training BS in Life Sciences or Engineering required. Minimum of 10 years of QA work experience in the medical device industry Technical Requirements Must have experience in implementation and maintenance of Electronic Quality Management System Experience with FDA QMSR requirements, knowledge of regulations such as GMP, ISO 13485 and other international regulatory requirements required. Good verbal and written communication skills; must interface well with all levels of the organization. Must work well independently and oversee work of others to achieve goals Must have initiative, judgment, and ability to manage multiple tasks with frequent interruptions with high attention to detail and accuracy. Excellent ability to work in a team environment and display a positive, can‑do attitude. Proficient computer skills(MS Office) ASQ certifications are preferred. Strong work ethic. Managerial Experience A minimum of 5 years of managerial experience managing quality assurance personnel in a fast‑paced environment Proven ability to manage, coach and mentor direct staff At Moximed we believe that the unique contributions of all our team members create our success. To ensure that our culture continues to incorporate every perspective and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, marital, veteran, or disability status Moximed offers a comprehensive benefits package including competitive pay, health insurance, Disability Insurance, 401K, paid time off plus holidays, and a flexible approach to work schedules. Pay range is $145-170K; actual pay will be adjusted based on an individual's skills, experience, education, and other job‑related factors such as location as permitted by law. Total compensation may also include additional forms of incentives. #J-18808-Ljbffr Moximed