Careers atAgile Search, Inc.

TITLE:  Quality Assurance Systems Engineer

THE OPPORTUNITY:   The Quality Assurance Systems Engineer will assume responsibility for a variety of key Quality Assurance compliance activities at a well established, yet dynamic and growing medical device company. 

The candidate will be either directly responsible for, or responsible for participating in, quality assurance and regulatory compliance activities associated with CAPA, training, internal and supplier auditing, and document change orders.

In addition the successful candidate will participate actively in the roll-out of an integrated Quality Management System software package.  This effort will minimally include development of process flows, supporting validation activities, and providing QMS training for implementation.

MAJOR DUTIES AND RESPONSIBILITIES:

• Responsibility for managing the Corrective and Preventive Action program,
• Perform internal and supplier audits as either a lead auditor, or, contributing auditor.
• Participate actively in the design and deployment of a QMS SW package i.e. CATSweb
• Support the development and maintenance of quality metrics as defined and approved by Executive Management during Management Review.
• Responsibility for managing the Quality Management System (QMS) Training compliance activities.
• Provide QMS orientation training when required.
• Participate in the review and approval of document/engineering change orders,
• Support other, pro-active Quality Management initiatives as required. 
  

QUALIFICATIONS

Skills/Abilities :

• Excellent communication skills, both written and oral
• Excellent Project Management skills
• Excellent knowledge of 21 CFR Parts 820 (QSR), ISO 13485, and ISO 14971 with previous experience with FDA inspections and Notified Body audits a plus
• Ability to multitask is a key success criteria
• A minimum of 5 years in the medical device industry; orthopedic or spine experience is a plus, but not required. 

Education/Certification: 

• Bachelors degree with demonstrated experience working in a regulated environment
• Auditor certification is required along with demonstrated experience conducting regulatory focused audits.