Job Description

Position Purpose: The Quality System Specialist is responsible for ensuring that the Quality Management System (QMS) is properly maintained and continuously improved in specific areas of expertise, including but not limited to document control, data integrity, and change control.

KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:

Support the Quality Department in specific QMS areas such as document control, data integrity, and change control linked to electronic in process controls that impact regulatory affairs, CAPA management, change control…

Develop and maintain the organization's QMS system for eIPC (electronic in-process control), including policies, procedures, work instructions, and forms, integrating central documentation into the local QMS.

Collaborate with local and central cross-functional teams to develop quality inspection plans in SAP system.  

Ensure the QMS is communicated and understood throughout the organization and employees are trained on QMS requirements.

Assess and determine the effectiveness of the QMS and identify opportunities for improvement.

POSITION REQUIREMENTS:

Minimum 1 year of experience within the quality profession (medical device or pharmaceutical preferred)

Highschool Diploma or Equivalent

Experience with SAP

Ability to use software productivity tools such as Statistical Process Control.

Knowledge of ISO 13485 and ISO 14971 (risk management)

Knowledge of digital QMS software

Ability to lift up to 30 lbs.

PREFERRED KNOWLEDGE/SKILLS:

Self-directed and possess excellent communication, oral, and written skills.

Capable of working with minimal supervision.

Ability to apply basic mathematical concepts.

Basic computer skills.

Knowledge of pharmaceutical GMPs

WORK ENVIRONMENT:

Office and clean room environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel.