Quality Systems Analyst: Change Control & PLM Specialist

Ledgent Technology; Irvine (CA); On-site; USD 34,440 - 61,992; Full time

Job summary

A staffing agency is seeking a Document/Change Control Analyst to support quality initiatives at a medical device company in Irvine, CA. The role requires 5-7 years of experience in quality and/or manufacturing, especially within the medical device sector. Primary responsibilities include managing change documents and collaborating cross-functionally to ensure compliance with quality standards. Ideal candidates will demonstrate exceptional attention to detail and possess critical problem-solving skills. This position is offered on a W2 hourly basis.

Qualifications

• 5-7 years of experience required in quality and/or manufacturing environment.
• Excellent written and verbal communication skills including negotiating and relationship management.
• Knowledge in medical device documentation development activities.

Responsibilities

• Support corporate quality strategic initiatives by documenting business requirements.
• Work with IT to develop functional specifications.
• Lead small scale projects requiring in-depth evaluation of multiple factors.

Skills

Critical thinking

Problem-solving

Communication skills

Attention to detail

Project management

Education

Bachelor's Degree or equivalent in related field

Tools

Windchill PLM

JDE

Job description

A staffing agency is seeking a Document/Change Control Analyst to support quality initiatives at a medical device company in Irvine, CA. The role requires 5-7 years of experience in quality and/or manufacturing, especially within the medical device sector. Primary responsibilities include managing change documents and collaborating cross-functionally to ensure compliance with quality standards. Ideal candidates will demonstrate exceptional attention to detail and possess critical problem-solving skills. This position is offered on a W2 hourly basis.