Senior Design & Construction Manager - Quality & Compliance

Illumina, Inc.; San Diego (CA); On-site; USD 156,000 - 233,000; Full time

Benefits offered by this job

Health benefits

Dental/Vision

Retirement plan

Paid time off

Job summary

Illumina, Inc. is seeking a Senior Manager for Design and Construction to lead validation engineering and manufacturing support within a FDA-regulated environment.

You will drive strategic goals, manage cross-functional project teams, and ensure validation programs meet 21 CFR Part 11, Part 820, ISO 9001/13485, IEC 62304 and MDSAP requirements while coordinating with scientists, engineers, and management.

Qualifications

• 12+ years of related experience with 3–6 years in management.
• Experience in medical device/IVD industry with Quality Systems
• Experience in front room and back room audit support
• 5–7 years in manufacturing, QA, or engineering in FDA-regulated env.
• Knowledge of FDA 21 CFR Part 11, Part 820; ISO 9001/13485; IEC 62304; MDSAP
• Proven ability to lead continuous improvement and manage timelines

Responsibilities

• Drive staff results by setting expectations, planning, monitoring, and coaching.
• Establish strategic goals from business and financial data; define objectives.
• Recruit, orient, train staff; ensure safe, compliant work environment.
• Ensure validation programs meet FDA/ISO/IEC requirements.
• Lead cross-functional teams and coordinate with scientists, engineers, and management.
• Oversee project milestones, timelines, and budget for validation and testing

Skills

Leadership

Project management

Quality Systems

CAPA

FDA regulations

Cross-functional teams

Tools

GxP compliance tools

Job description

Illumina, Inc. is seeking a Senior Manager for Design and Construction to lead validation engineering and manufacturing support within a FDA-regulated environment.

You will drive strategic goals, manage cross-functional project teams, and ensure validation programs meet 21 CFR Part 11, Part 820, ISO 9001/13485, IEC 62304 and MDSAP requirements while coordinating with scientists, engineers, and management.