Doc Control Specialist

Job Title:

Quality Control Specialist Job Description

We are seeking a Quality Control Specialist to join our team and contribute to the successful execution and modification of our Quality Management System (QMS) through February 2027. The role involves ensuring compliance with both internal and external regulatory requirements, as well as engaging in the development of an optimized future state of QMS to meet business needs.

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

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

• Drive improvements and inputs into the quality planning process.

• Execute development and/or modification of the Quality Management System.

• Manage and participate in Management Review and Quality Planning Review and related forums.

• Assess and quantify requirements for QMS to optimize its structure.

• Promote GMP and GDP within the Quality organization.

• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.

• Contribute to the development, maintenance, and improvements of policies and procedures.

• Ensure implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements.

• Facilitate notified body communication.

• Ensure QMS reflects actual activities and supports New Product Development (NPD) requirements.

• Participate in relevant QMS IS discussions.

• Contribute to QMS business processes and understand IS system support requirements.

• Participate in internal and external quality system audits.

• Understand system integration.

• Assist in IS change control assessment and approval.

• Document control, QMS, ECO's, ECR's, Medical Device, Quality Systems, 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 Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.

• Ability to read and interpret CAD drawings.

• Experience interacting with regulatory agencies such as FDA, MoH, TUV.

• Thorough knowledge of US and International Medical Device Regulations.

• Strong knowledge of Quality Concepts such as CAPA, Audits, Statistics.

• Strong project management skills and ability to manage multiple tasks simultaneously.

• Ability to advocate for product excellence and quality.

• Experience working cross-functionally with departments like Advanced Operations, Product Development, Regulatory Affairs, and Marketing.

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

• Critical thinking and "outside the box" thinking.

• Highly developed problem-solving skills and 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 program.

The position offers a supportive work environment with benefits including 3 weeks of PTO and 10 paid holidays. The role involves working with advanced technologies and equipment within a structured facility. Dress code is professional attire, and the work hours are standard business hours.

This is a Contract position based out of Irvine, CA.

The pay range for this position is $40.00 - $55.00/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…