Job Type:Full time

Location:Morrisville, NC 27560 & Durham, NC 27703

Summary: The Quality Specialist is responsible for ensuring that Carolina Components Group’s Quality Management System (QMS) is maintained in compliance with the site’s most current ISO 9001 standard. This individual will possess an understanding of both the current ISO 9001 standard, cGMP processes and its quality requirements. This position is responsible for all aspects of the Quality System maintenance including but not limited to: compiling/maintaining control of records, drawings, and procedures related to the engineering, manufacture, and quality control of products; primary Quality support for site validation and calibration activities; Engineering Design Drawing Reviewer/Approver; integrator of new Quality systems into the site’s QMS and Quality Processing Systems; compiler and primary initial evaluator of quality metrics including internal and external metrics; CAPA generator /Follow-Up For Effectiveness Results based on metric evaluation; CAPA program administrator, perform Technical writing and reviewer of the site’s procedures/work instructions/validation/qualification documents as needed.

Additionally, this person will serve as primary site support to the site Quality Director for all QMS and Customer audit activities.

Essential Duties and Responsibilities:

• Responsible for maintaining Quality System documents in compliance with cGMP, and ISO:
  • Change Orders.
  • Quality Manual.
  • Customer Complaint Files.
  • CAPA.
  • Validation Documents
  • Working and Controlled pdf Site Documentation (SOPS, Work Instructions, Forms)
• Generate, develop and/or implement Quality Programs for the site to improve the effectiveness of the QMS and/or Quality Business processing.
• Manage the equipment certification program and schedules; oversees annual re-certification.
• Oversee the site’s validation/qualification program, including execution and results review of quarterly qualification audits
• Provide regulatory advice and guidance to supervisors or managers and cross-functional project teams as needed to ensure regulatory compliance requirements are met.
• Maintains hardcopy document files in organized fashion:
  • Maintains current original as well as archiving previous releases in a well organized manner per the site’s document retention program.
• Releases and distributes new revisions of documents:
  • Performs a document review for completeness of information and checks for obvious documentation errors. Gathers any missing signatures as required prior to release.
  • Copies and distributes new revision to all user locations.
  • Organizes and Manages electronic files in various directories.
  • Assists users in completing change request forms.
  • Compiles and posts monthly, quarterly, and yearly document metrics.
•  Maintains complaint system:
  • Creates files for new complaints.
  • Enters new complaints into database.
  • Review status of open complaints.
  • Compiles and posts monthly, quarterly and yearly graphic trending of complaints.
  • Assist in all aspects of complaint reporting, follow up actions, and facilitate resulting corrective actions.
• Responsible for compiling departmental metrics and reports as requested.
• Charts and posts production build and rework metrics on a monthly basis.
• Responds to official inquiries regarding the Company’s documentation in Quality Control.
• Leads preparation and execution of all Quality System audits, trains team members to ensure compliance with Quality processes and requirement.
• Technical writing (Standard Operating Procedures, Work Instructions, Quality Forms).
• Assist with preparation and follow up of Management review meetings.
• Organize Material Review Board (MRB) meetings as needed.
• Performs other duties as assigned.

Desired Education:

• Bachelor’s degree and/or 3-5 years relevant industry experience

Desired Experience:

• FDA regulated experience if site required
• Minimum of 2-3 years’ experience in an ISO and/or equivalent quality assurance environment

Desired Knowledge, Skills, and Expertise:

• Proficiency in file management
• Proficiency in word processing
• Proficiency in preparing and analyzing results
• Excellent analytical and organizational skills
• Good written and verbal communication skills
• Detail oriented with excellent organizational skills
• Ability to address, communicate, and implement changes quickly and effectively
• Ability to work in a high-intensity, fast-paced environment
• Ability to probe for information
• Creative thinking and ability/desire to think “outside of the box”
• Team player