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Qa Specialist Jobs

Company

ARC-One Solutions
Address , Miramar, 33023, Fl
Employment type FULL_TIME
Salary
Expires 2023-10-07
Posted at 9 months ago
Job Description
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.
  • Promotes culture of quality and mentors cross-functional teams
  • Provides administrative support to all Information Technology departments as required.
  • Creates and monitors reports for departmental key performance indicators, tracks and trends
  • Coordinates quality and regulatory compliance training programs for the department
  • Administers the document control system including monitoring, cataloging and reporting on the status and stages of various documents
  • Provides support to the supplier management process
  • Manages the medical device complaint process including documentation and fielding of issues to the appropriate parties for investigation and resolution
  • Organizes documents for management review, software release, and audits
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
  • Skill in Microsoft Office applications.
  • Ability to multi-task, meet deadlines and focus on critical projects
  • Ability to work independently with minimal supervision
  • 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 communicate effectively orally and in writing
  • Ability to follow complex oral and written instructions
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.