Principal Quality Systems Change Control Analyst

Fresenius - Pleasant Hill, CA

Full-time - Mid Level

Pleasant Hill, CA

Ambulatory Health Care Services

About the position

The position is responsible for managing and improving Corporate Change Control processes across all FMCRTG manufacturing sites. The role involves acting as a representative for change control activities, supporting senior leaders, and coaching managers in adopting new changes. The individual will also define success metrics, conduct training, and ensure compliance with quality assurance requirements.

Responsibilities

• Provide process guidance and support for Corporate Change Control processes.
• Act as the representative for change control activities at assigned locations.
• Develop, implement, and improve Change Control processes.
• Support and engage senior leaders and coach managers in change adoption.
• Define and measure success metrics for change progress.
• Conduct hands-on training as a Change Control Process SME.
• Review and audit change control notices for compliance.
• Monitor and prioritize business needs to close activities timely.
• Conduct quality assessment reviews and assess compliance and quality trends.
• Create and publish meaningful data across the enterprise.
• Support external agency inspections utilizing FMCRTG inspection processes.
• Mentor other staff and assist with complex tasks.

Requirements

• Bachelor's Degree in a technical or related scientific field required.
• Minimum 8 - 12 years of experience in a medical device or highly regulated industry.
• Experience in Learning and Development or Training environment required.
• Strong knowledge of Medical Device QMS and regulatory requirements.
• Demonstrated understanding of product development lifecycles and change control.
• Experience supporting FDA inspections or ISO audits preferred.
• Adept in MS Word, Excel, PowerPoint, and statistical packages.
• Experience with process verification and validation methodologies.
• Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies.
• Excellent oral communication and report writing skills.
• Exceptional analytical and problem-solving skills.

Nice-to-haves

• CQE, CQA, CQM, or Six Sigma certification preferred.
• Experience participating in cross-functional teams.

Benefits

• Competitive salary based on qualifications and experience.
• Commitment to sustainability and employee recognition programs.