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Job Title: Quality Management Systems (QMS) SpecialistJob Description

We are seeking a dedicated Quality Management Systems (QMS) Specialist who will play a crucial role in ensuring compliance with internal and external regulatory requirements. This role involves engaging in the development of future state QMS for business needs, executing modifications, and contributing to the quality planning process.

Responsibilities

+ Ensure QMS compliance with appropriate internal and external regulatory requirements, including FDA, ISO, MDD, and individual country standards.

+ Engage in the development of optimum future state QMS for business needs.

+ Drive improvements and inputs into the quality planning process.

+ Execute development and/or modification of QMS.

+ Participate in Management Review and Quality Planning Review forums.

+ Assess and quantify requirements for QMS optimization.

+ Promote GMP and GDP within the Quality organization.

+ Identify and implement improvement opportunities to increase 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.

+ Facilitate notified body communication.

+ Ensure QMS supports actual activities, business needs, and NPD requirements.

+ Participate in relevant QMS IS discussions.

+ Manage internal and external quality system audits.

+ Understand system integration and IS change control assessments and approvals.

Essential Skills

+ Proficiency in document control, QMS, ECO's, ECR's, and Medical Device Regulations.

+ 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 in interacting with regulatory agencies (FDA, MoH, TUV, etc.).

+ Strong knowledge of US and International Medical Device Regulations.

+ Strong understanding of Quality Concepts (e.g., CAPA, Audits, Statistics).

+ Project management skills and ability to manage multiple tasks simultaneously.

+ Ability to advocate for product excellence and quality.

Additional Skills & Qualifications

+ Strong interpersonal, written, oral communication, and negotiation skills.

+ Critical thinking and 'outside the box' thinking.

+ Highly developed problem-solving skills.

+ Strong analytical skills.

+ Ability to manage and complete projects in a matrix organization.

+ Ability to work independently.

+ Experience in compliance risk situations.

+ Computer literacy, including proficiency with Mini-Tab or similar analysis programs.

Work Environment

The position offers a supportive work environment with benefits including 2 weeks of PTO and 10 paid holidays. The role requires interaction with various departments such as Advanced Operations, Product Development, Regulatory Affairs, and Marketing, fostering a collaborative and cross-functional workspace.

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 31, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.