Healthcare Qa Specialist Jobs

Overview:

Ensures site activities associated with medical device manufacturing and testing comply with quality management systems and applicable regulatory requirements. Coordinates quality management systems, ensuring compliance with all relevant regulations and standards, including FDA QSR Part 820. Conducts corrective and preventive action planning and implementation, change management, record retention, and training, and assists with the internal audit program.

Responsibilities:

• Works independently on assignments and prioritizes daily workload
• Administers corrective and preventive action programs; coordinates corrective action plans and verification activities; works with process owners to perform root cause analysis, correction planning, and corrective and preventive action implementation
• Monitors, catalogs, and reports on the status and stages of various documents within the document control system
• Organizes documents for management review, software release, and audits
• Promotes a culture of quality and mentors cross-functional teams
• Creates and monitors reports for departmental key performance indicators
• Coordinates quality and regulatory compliance training programs
• Provides support to the supplier management process
• Manages and documents the medical device complaint process; delegates issues to the appropriate parties for investigation and resolution

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION AND/OR EXPERIENCE:

Associates degree from an accredited college or university, two (2) years of experience in regulated quality assurance or blood bank environment, prior customer relations experience, or an equivalent combination of education, training and/or experience.

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to communicate effectively orally and in writing
• Ability to write general business-related correspondence, and procedures, review and modify reports
• Ability to multi-task, meet deadlines and focus on critical projects
• Working knowledge of FDA and international medical device regulations
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
• Ability to organize work for timely completion
• Ability to work independently with minimal supervision
• Ability to follow complex oral and written instructions
• Skill in Microsoft Office applications

ENVIRONMENTAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.

Functions are regularly performed inside without potential for exposure to adverse conditions, such as inclement weather, atmospheric elements and pathogenic substances.