Job Information
Actalent Document Control in Irvine, California
Job Title: Quality Management Systems (QMS) Specialist
For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.com with the following:
1) Word copy of resume
2) 2-3 professional references
3) 4-5 brief bullet points highlighting technical qualifications
Job Description
We are seeking a detail-oriented and experienced Quality Management Systems (QMS) Specialist to ensure compliance with both internal and external regulatory requirements. The ideal candidate will contribute to the development, maintenance, and improvement of our client's QMS, ensuring it meets business needs and supports new product development requirements.
Responsibilities
Ensure QMS compliance with internal and external regulatory requirements, including Site, Division, Corporate, FDA, ISO, MDD, and individual country regulations.
Engage in the development of an optimum future state QMS for business needs.
Identify and implement QMS improvements and provide input into the quality planning process.
Execute the development and/or modification of the QMS.
Participate in Management Review and Quality Planning Review and related forums.
Assess and quantify QMS requirements to optimize its structure.
Promote GMP and GDP within the Quality organization.
Identify and implement improvement opportunities to enhance QMS efficiency and effectiveness.
Develop and deliver QMS training.
Contribute to the development, maintenance, and improvement of policies and procedures.
Implement best-in-class practices and benchmark against industry leaders and regulatory requirements.
Ensure effective communication with notified bodies.
Ensure QMS reflects actual activities and business needs while supporting NPD requirements.
Participate in relevant QMS IS discussions.
Contribute to QMS business processes and understand IS system support requirements.
Support internal and external quality system audits.
Understand system integration and assess IS change control.
Engage in basic project management.
Essential Skills
Experience with medical device product development lifecycle, including risk management and design/process verification and validation.
Applied knowledge of Advanced Quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
Ability to read and interpret CAD drawings.
Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
Thorough knowledge of US and International Medical Device Regulations.
Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
Strong project management skills and ability to manage multiple tasks simultaneously.
Ability to advocate for product excellence and quality.
Effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
Strong interpersonal, written, oral communication, and negotiation skills.
Strong critical thinking and 'outside the box' thinking.
Highly developed problem-solving skills.
Strong analytical skills.
Ability to successfully manage and complete projects in a matrix organization.
Ability to work independently.
Experience working in a compliance risk situation.
Computer literacy, including proficiency with Mini-Tab or similar analysis programs.
Additional Skills & Qualifications
- Knowledge of document control, QMS, ECOs, ECRs, and Medical Device Regulations.
Work Environment
Enjoy 2 weeks of PTO and 10 paid holidays. Work in a dynamic environment that values quality and compliance, with opportunities for professional growth and cross-functional collaboration.
Pay and Benefits
The pay range for this position is $32.00 - $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 Type
This is a fully onsite position in Irvine,CA.
Application Deadline
This position is anticipated to close on May 7, 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.