Quality Assurance Project Coordinator

Summary of Job Position:

Responsible for coordinating Quality Plans across departments to help in improving, maintaining, and sustaining the Quality Management System (QMS). Assist with technical and commercial documents for the company; maintain the flow of both electronic and hard-copied controlled documents, files, and resource materials. Maintains and updates computerized document/records system and ERP system (company-wide electronic information system) with critical information used throughout all facets of Production operations. Maintains confidentiality as this position works with intellectual and proprietary company information, both internal and external to the organization.

Essential Duties and Responsibilities

• Core Responsibilities: Project Coordination and Management of Quality Assurance projects across multiple departments and functions.
  • Lead and coordinate Quality Assurance projects across multiple departments and functional areas.
  • Plan, track, and execute QMS transformation initiatives, including:
    • Implementation of electronic Change Control processes
    • Implementation of electronic Nonconformance and deviation or temporary change processes
    • Migration of quality records and workflows from legacy systems to new electronic QMS platforms
  • Develop and maintain project plans, timelines, milestones, and status updates for QA system initiatives.
  • Coordinate cross‑functional stakeholders to ensure project objectives, regulatory requirements, and timelines are met.
  • Identify risks, dependencies, and resource needs associated with QA projects and escalate as needed.
  • Support project validation, user readiness, and training activities related to electronic QMS implementations.
• Supporting Responsibilities: QMS and Document Control Support
  • Supports the maintenance of the overall Document Control System - Generates/manages Change Orders (CO) for technical documentation used in a medical device manufacturing operation; secures signatures and approvals on CO's. Train and mentor users of the system to ensure success.
  • Maintains and implements computerized systems to electronically store, retrieve, update, and distribute engineering and manufacturing documentation.
  • Assists in the development of all types of company documentation and resolving document control issues.
  • Enters Bills of Materials (BOMs) and modifies BOMs as required by Engineering changes (Change Order).
  • Performs document reviews and archiving of product build configuration records including Operations Traveler, BOM, and "As-Built" (Lot History Record), as well as QA inspection/test records.
  • Maintains records and ensures accuracy of documentation (in accordance with Good Documentation Practices); scan, image, organize and maintain documents, adhering to record retention policies.
  • Ensures timely and accurate revisions to and distributions of pending and approved company documentation relating to policies, procedures, processes and products.
  • Engages internal and external customers as required to execute data management functions.
  • Fulfills labeling requests for production work orders and finished product quality certificates.

Participates in internal quality audits and supports facility audits conducted by customers and regulatory agencies.

Qualifications

• Life Science associate's degree, bachelor's degree* preferred plus four years medical device related experience (or equivalent combination in skills and education).* Biology, Chemistry, Biotechnology, Physiology, Microbiology, Histology
• Must be a self-starter with strong interpersonal skills and ability to work with others in a positive and collaborative manner.
• Good knowledge and skills in the use of advanced personal computer productivity programs for word processing, spreadsheets, database manipulation, presentations and flow charts; including imaging software (Adobe Acrobat).
• Must have experience with software implementations for eQMS or projects focusing on paper-based to electronic transitions.
• Experience with SAP is greatly desired.
• Working knowledge of Change Control, Nonconformance, Deviations, and DMR processes.
• Experience with Design Control and Supplier Management preferred but not required.
• Demonstrate effective planning and organizational skills, with the ability to work with a high degree of accuracy and recall.
• Ability to follow instructions/schedules/timelines and handle multiple priorities in a dynamic environment.
• Preferred experience with reading and understanding technical drawings and specifications; and symbolism used in high-tech manufacturing (i.e., geometric dimensioning, formulas, scientific equations, graphs, etc.).
• Working knowledge of medical device and IVD quality regulations and standards. Certifications to ISO 13485 preferred.