Doc Control Specialist

Overview

Ensure QMS compliance and drive improvements for medical device regulations

Key Responsibilities

• qms development
• compliance management
• process improvement
• system integration
• audits
• regulatory liaison

Tasks

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

Requirements

• document control
• minitab
• fmea
• capa
• project management
• iso

What You Bring

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

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Benefits

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

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms