Job Title: Technical WriterJob DescriptionWrite, edit, and format new and existing procedures, work instructions, and supporting documents in collaboration with subject matter experts (SMEs). Review existing procedures, interpret them, and re-edit them to accommodate new processes. Ensure all documentation adheres to industry and company standards, promoting consistent quality and operational practices. Liaise with department heads, process owners, and SMEs to understand and capture essential process steps accurately. Conduct reviews to ensure documentation aligns with regulatory standards. Identify gaps and recommend improvements in existing procedures to streamline operations and enhance efficiency. Process document revision per Product Lifecycle Management (PLM) system.Responsibilities
Write, edit, and format new and existing procedures, work instructions, and supporting documents.
Review existing procedures, interpret them, and re-edit to accommodate new processes.
Ensure all documentation adheres to industry and company standards.
Liaise with department heads, process owners, and SMEs to accurately capture essential process steps.
Conduct reviews to ensure documentation aligns with regulatory standards.
Identify gaps and recommend improvements in existing procedures.
Process document revision per PLM system.
Essential Skills
Technical writing
Medical device documentation
Document management
ERP system proficiency
Compliance and Quality Assurance
Process Standardization
ISO13485
Continuous improvement
Document control
PLM
Quality Assurance
Regulatory knowledge
FDA standards
SOP creation
Engineering principles
Additional Skills & Qualifications
Bachelor's Degree in Engineering, Business, or related field
Minimum 3-5 years of experience in technical writing in the medical device field
Working experience with PLM
Thorough understanding of QMS processes
Proficiency in MS Office and documentation tools (e.g., Confluence, Adobe)
Knowledge of process improvement frameworks like Lean, Six Sigma, or similar methodologies
Work EnvironmentMedical device manufacturing - a global leader in breakthrough cardiovascular and endovascular solutions. You will be part of a team with 2 other Technical Writers. This role requires onsite presence 100% of the time. The company offers a collaborative, hard-working, and fun team culture with growth opportunities as the company has doubled in size in the last 6 months.Pay and BenefitsThe pay range for this position is $28.00 - $35.00/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 TypeThis is a fully onsite position in Irvine,CA.Application DeadlineThis position is anticipated to close on Feb 15, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.