Title
Manager Software Quality Assurance
Job ID
2020-6851
Location
Miramar - ARC-One
Geographic Location
US-FL-Miramar
Category
Information Technology

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 to all relevant regulations and standards including FDA QSR Part 820; including change management, record retention, training, and assist with the internal audit program.

Responsibilities

The list of essential functions, as outlined herein, is intended to representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

  • Organizes documents for management review, software release, and audits
  • Creates and monitors reports for departmental key performance indicators, tracks and trends
  • Administers the document control system including monitoring, cataloging and reporting on the status and stages of various documents
  • Manages the medical device complaint process including documentation and fielding of issues to the appropriate parties for investigation and resolution
  • Coordinates quality and regulatory compliance training programs for the department
  • Promotes culture of quality and mentors cross-functional teams
  • Provides support to the supplier management process
  • Provides administrative support to all Information Technology departments as required.  

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 and two (2) years of experience in a laboratory or blood bank environment as well as prior customer relations experience or an equivalent combination of education, training and/or experience.  

 

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:

None

 

KNOWLEDGE, SKILLS AND ABILITIES:

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

PHYSICAL REQUIREMENTS:

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

 

Functions involve the ability to exert light physical effort in sedentary to light work, which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (up to 20 pounds).

 

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.

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed