Sr Quality Engineer II - Combination Products

Scorpion Therapeutics; California (MO); On-site; USD 140,000 - 200,000; Full time

Job summary

Scorpion Therapeutics seeks a Lead Quality Engineer to oversee medical device combination products, with a focus on design controls, risk management, and lifecycle quality oversight. You will drive design verification and validation plans and lead risk analyses per ISO 14971.

Partnering with Device Engineering on development activities, you will ensure compliance with FDA and ISO standards, lead quality-improvement initiatives, and resolve complex technical and quality issues with

Qualifications

• Bachelor's in Engineering or scientific discipline with relevant QA experience.

Responsibilities

• Partner with Device Engineering on development activities.
• Ensure compliance with FDA, ISO, and internal quality standards.
• Lead quality improvement initiatives.
• Resolve complex technical and quality issues with cross-functional teams and CMOs.
• Support change control assessments.
• Develop controlled documentation.

Skills

QA experience

Design controls

Risk management

Cross-functional collaboration

Change control

Education

Bachelor's in Engineering or scientific discipline

Job description

Role: Lead Quality Engineer for medical device combination products, focusing on design controls, risk management, and lifecycle quality oversight.

Responsibilities:

• partner with Device Engineering on development activities
• ensure compliance with FDA, ISO, and Gilead quality standards
• lead quality improvement initiatives
• resolve complex technical and quality issues with cross-functional teams and CMOs
• support change control assessments
• and develop controlled documentation.

Qualifications:

• Bachelor's in Engineering or scientific discipline with ≥8 years (Master's with ≥6 years) of relevant QA experience, with strong background in medical devices and combination products.

Preferred:

• 10+ years supporting combination products like autoinjectors or pre-filled syringes, expertise in design controls, risk management (ISO 14971), statistical methods, process improvement, and manufacturing operations.

HighValue:

• medical device/combination product focus
• lifecycle management
• design verification/validation
• risk management
• regulatory compliance
• and cross-functional collaboration.

WorkSetup:

• Not specified.