Quality Management Systems (QMS) Specialist (W2)

Title: Document Control Coordinator - QMS

Location: Irvine, CA Onsite

Document Control Specialist QMS

Job 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.