What are the responsibilities and job description for the Document Control Specialist position at Actalent?
**If you are interested, please send the following to bmuratalla @astoncarter.com**
- updated resume
- 3-4 bullet points explaining how your experience relates
- 3 professional references
Key Responsibilities
Document Control: Manage and maintain all quality documentation, including quality manuals, procedures, and plans. Ensure all documentation is accurate, complete, and compliant with regulatory standards.
CAPA (Corrective and Preventive Actions): Implement and monitor CAPA processes to address non-conformances and customer complaints. Ensure the effectiveness of corrective actions through follow-up audits and reviews.
Quality Management System (QMS): Manage and maintain the QMS, ensuring adherence to applicable standards and regulations. Conduct internal and external audits to ensure compliance and timely resolution of audit findings.
Quality Assurance Integration: Collaborate with product development and manufacturing teams to integrate quality standards into all processes.
Risk Assessments: Conduct risk assessments and failure mode effects analysis (FMEA) for new and existing products.
Quality Control Methods: Develop and implement quality control methods, procedures, and performance metrics for product design and manufacturing.
Problem Solving: Lead problem-solving and improvement activities to address quality issues and reduce product and process nonconformities.
Process Audits: Conduct audits of design and manufacturing processes to ensure compliance with quality system requirements and identify opportunities for improvement.
Data Analysis: Compile and analyze statistical data to identify and prioritize areas for quality improvement.
Reporting: Prepare and present reports on product and process quality to management and customers.
Training and Mentoring: Train and mentor staff on quality system requirements, quality tools, and best practices.
Skills
Document control, Quality assurance, medical device, Quality control
Top Skills Details
Document control,Quality assurance
Additional Skills & Qualifications
Education: Bachelor’s degree in Engineering, Quality Assurance, or a related field.
Experience: 1-3 years of experience in quality assurance or a related role.
Skills:
Strong knowledge of document control processes and systems.
Proficiency in CAPA processes and methodologies.
Thorough understanding of Quality Management System (QMS) standards and regulations.
Familiarity with product design and manufacturing processes.
Proficiency in quality tools and statistical analysis.
Excellent analytical and problem-solving skills.
Strong communication and interpersonal skills.
Ability to work collaboratively in a team environment.
Preferred Qualifications
Experience with ISO 13485:2016 and 21 CFR Part 820 standards.
Knowledge of risk management and FMEA.
Experience in conducting process audits and quality control.
Experience Level
Intermediate Level
Pay and Benefits
The pay range for this position is $35.00 - $45.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Irvine,CA.
Application Deadline
This position is anticipated to close on Apr 30, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $35 - $45
