Doc Control Specialist

Description

• Support policy and procedure development, maintenance, and optimization.
• Facilitate Management Review and Quality Planning forums.
• Identify and implement improvements to enhance QMS efficiency and effectiveness.
• Benchmark best-in-class practices and ensure alignment with industry and regulatory expectations.
• Conduct internal and external audits and support compliance risk assessments.
• Promote GMP and GDP principles across the Quality organization.
• Manage communications with notified bodies and regulatory agencies.
• Ensure QMS compliance with internal standards and external regulatory requirements.
• Lead development and modification of QMS processes to align with business needs.
• Collaborate with cross-functional teams including Product Development, Regulatory Affairs, and Advanced Operations.
• Participate in QMS-related IS discussions and support system integration and change control processes.

Requirements

• Strong grasp of CAPA, audit processes, and statistical analysis.
• Ability to read and interpret CAD drawings.
• Proficiency in EU MDR, ISO standards, and CFR requirements.
• Familiarity with ECOs and ECRs.
• Experience in the medical device product development lifecycle, including risk management and design/process verification and validation.
• Project management expertise and ability to work independently.
• Proven experience interacting with regulatory bodies (FDA, MoH, TUV).
• Deep understanding of QMS principles and quality systems.
• Knowledge of advanced quality tools such as FMEA, GD&T, Root Cause Analysis, and Poka Yoke.
• Experience working in a matrixed organization and managing cross-functional projects.
• Strong experience in document control and medical device regulations.
• Proficiency in MiniTab or similar statistical analysis software.

Benefits

• Employee Assistance Program
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Critical Illness, Accident, and Hospital
• Time Off/Leave (PTO, Vacation or Sick Leave)
• Transportation benefits
• Medical, dental & vision
• Health Spending Account (HSA)
• Short and long-term disability
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Training + Development

Interview process

Visa Sponsorship

Security clearance