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Doc Control Specialist
Actalent
Ensure QMS compliance, develop and optimize quality systems, and support audits.
1d ago
$40 - $55
Expert & Leadership (13+ years)
Full Time
Irvine, CA
Onsite
Company Size
5,000 Employees
Service Specialisms
Technical consultation
Performance analysis
Physical development
Injury prevention and recuperation
Sports psychology
360° Marketing
Consultancy with clubs and sporting entities
Legal services
Sector Specialisms
Utilities
Power
Automotive
Food and Beverage
Consumer Products
Industrial Goods
Manufacturing
Mechanical Engineering
Role
What you would be doing
qms development
qms optimization
regulatory compliance
gmp compliance
quality audits
process improvement
- Act as a key contributor to QMS business processes and understand IS system support requirements.
- Ensure QMS reflects actual activities and business needs, and supports NPD requirements.
- Participate in Management Review, Quality Planning Review, and related forums.
- Facilitate communication with notified bodies.
- Execute the development and/or modification of the QMS.
- Engage in the development of an optimal future state of QMS for business needs.
- Ensure GMP and GDP compliance within the Quality organization.
- Assess and quantify requirements for optimizing QMS structure.
- Ensure QMS compliance with site, division, corporate, FDA, ISO, MDD, and individual country requirements.
- Participate in internal and external quality system audits.
- Identify and implement improvement opportunities to enhance the efficiency and effectiveness of the QMS.
- Participate in relevant QMS IS discussions.
- Contribute to the development, maintenance, and improvement of policies and procedures.
- Implement best-in-class practices and benchmark against industry leaders and regulatory requirements.
- Provide improvements and inputs into the quality planning process.
What you bring
fmea
gd&t
mini-tab
capa
project management
regulations
- Applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
- Experience working in compliance risk situations.
- Knowledge of Medical Device Regulations.
- Strong interpersonal, written, oral communication, and negotiation skills.
- Computer literacy, including proficiency with Mini-Tab or similar analysis programs.
- Strong project management skills and the ability to manage multiple tasks simultaneously.
- Effective cross-functional collaboration skills with departments including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
- Ability to work independently.
- Ability to read and interpret CAD drawings.
- Ability to manage and complete projects in a matrix organization.
- Ability to advocate for product excellence and quality.
- Knowledge of document control, QMS, ECOs, ECRs, Medical Device, and Quality Systems.
- Thorough understanding of US and International Medical Device Regulations.
- Experience with medical device product development lifecycle, including risk management and design/process verification and validation.
- Strong knowledge of Quality Concepts such as CAPA, Audits, and Statistics.
- Critical and analytical thinking skills.
- Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
- Experience as a Configuration Specialist or in Doc Control.
- Understand system integration and IS change control assessment and approval.
- Time Off/Leave (PTO, Vacation or Sick Leave)
- Health Spending Account (HSA)
- Employee Assistance Program
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Transportation benefits
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- Short and long-term disability
Information not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearanceInformation not given or found
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Company
Overview
$1.3B Annual Revenue
Revenue Figure
Generated annually through a network of technical and consulting services.
27,500+ Consultants
Consultants Network
Comprises a global network of expert professionals across industries.
- 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.
- We empower people to realize their full potential by providing opportunities to grow and learn.
- We build lasting relationships based on trust, integrity, and respect.
- We champion innovation, continuously seeking creative solutions.
- We are committed to delivering exceptional results for our clients and employees.
- We foster a collaborative environment where team members contribute to collective success.
2050
Target Year
The company has set a goal to achieve net-zero emissions by the year 2050.
- focused on reducing its carbon footprint and enhancing environmental sustainability.
- committed to making energy-efficient investments and improving operational practices for sustainability.
- focuses on reducing waste and increasing recycling in its operations.
- This company prioritizes creating an inclusive workplace where diverse perspectives are valued.
- The organization strives to increase gender diversity and empower women at all levels.
- The company regularly monitors and tracks progress on gender-related diversity goals.
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