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CQ Medical · 3 weeks ago

Document Control Specialist II

Avondale, PA

Full-time

Onsite

Mid Level

3+ years exp

CQ Medical is seeking a Document Control Specialist II to maintain control of all quality documentation while working independently with minimal supervision. The role involves organizing, maintaining, and updating controlled documents, ensuring compliance with quality systems and regulations, and leading Document Control Quality projects.

Health CareMedical DeviceWholesale

Growth Opportunities

Responsibilities

Processes, releases, and Controls Engineering Change Orders

Responsible for creating part numbers and Bill of Materials (BOMs) in the ERP system

Processes, maintains, and monitors deviations

Processes, releases, and Controls all Quality documents (e.g. Standard Operating Procedures (SOPs), Risk Management Documents, Technical Documents, etc.) supporting the lifecycle of product documentation

Manages the calibration of all calibrated equipment and ensures all calibrated equipment is within specification and certification, as required, is maintained

Supports the Head of Quality to establish and maintain Quality Systems in a compliant manner

Interacts with manufacturing and design engineering, quality regulatory, marketing, customer service, and management

Writes, creates, updates, and submits Quality SOPs, Forms, Templates and other Quality documents for review and approval

Leads Document Control Quality projects and drives the projects to completion within established deadlines

Identifies continuous improvements in Document Control processes and drives and implements those improvements

Promotes a work environment of continuous improvement that supports CQ Medical's Quality Policy, Quality System, and the appropriate regulations

Assists with communicating business related issues or opportunities for improvement to management

Accountable for document control compliance with applicable US and International regulations and directives including, but not limited to, Food & Drug Administration (FDA), Canadian, and EU MDR regulations

Assists with creating, editing, and proofreading documents

Maintains Document Control systems

Archives obsolete and historical documents

Creates and maintains part numbers and Bill of Materials in ERP/MRP system

Monitors training history documentation

Works in a team environment to achieve metrics and business goals

Collaborates with engineering and other stakeholders to process Engineering Change Orders in a timely manner for optimal customer service and business needs

Key stakeholders include but not limited to, Quality, Engineering, Purchasing, Marketing, Regulatory, Customer Service, and Manufacturing

Leads and maintains the Layered Process Audit program

Leads Quality Projects related to Document Control and drives projects to completion

Supports management review and all audits/inspections

Maintenance of Quality procedures

Administrates of the Calibration program

Assists with CAPAs related to Document Control

Assists with internal audit program

ISO 13485:2016 & EU-MDR 2017/45 Lead Internal Auditor

Drives Continuous Improvement projects

Writes, creates, updates, and submits Quality SOPs, Forms, Templates and other Quality documents for review and approval

Remain current on all required training

All other job functions as assigned

Qualification

Quality Management SystemDocument ControlISO 13485Engineering Change OrdersMS Office SuiteProofreadingOrganizational SkillsProblem-SolvingWritten CommunicationDecision-MakingAttention to Detail