Senior Quality Engineer – Medical Device & Pharma

Central Business Solutions; Tempe (AZ); On-site; USD 110,000 - 115,000; Full time

Benefits offered by this job

Base salary USD 110,000–115,000

Full-time benefits

Relocation assistance available

Job summary

Central Business Solutions is seeking a Mid-Senior Quality Engineer to provide technical leadership in medical device and pharmaceutical operations. You will lead risk assessments, develop and validate test methods, and ensure compliance with ISO 13485/14971 and 21 CFR.

The role includes coordinating design reviews, product development, and supplier audits. The ideal candidate has 8+ years in engineering/quality within healthcare devices, with strong root cause analysis and cross-functional

Qualifications

• BS in Engineering or related field; advanced degrees preferred.
• 8+ years in engineering/quality engineering in medical device/pharma.
• Proven design controls experience in development stage.
• Pharmaceutical or combination product experience.

Responsibilities

• Provide technical leadership in medical device and pharmaceutical operations.
• Lead risk assessments and development/validation of test methods.
• Coordinate design reviews and product development activities.
• Ensure compliance with ISO 13485, ISO 14971, and 21 CFR requirements.
• Lead root cause analysis and corrective actions.
• Support regulatory submissions and supplier audits.
• Mentor team members and drive project planning, budgeting, and tracking.

Skills

Quality Engineering

Risk assessment

Statistics

Test protocols

Regulatory knowledge

Cross-functional leadership

Root cause analysis

Process validation

Design controls

Communication

Education

Bachelor's degree in Engineering/Biology or related

Masters/Ph.D. preferred

Tools

Equipment qualifications

Test method development tools

Quality tools (Sampling Plans)

Job description

Central Business Solutions is seeking a Mid-Senior Quality Engineer to provide technical leadership in medical device and pharmaceutical operations. You will lead risk assessments, develop and validate test methods, and ensure compliance with ISO 13485/14971 and 21 CFR.

The role includes coordinating design reviews, product development, and supplier audits. The ideal candidate has 8+ years in engineering/quality within healthcare devices, with strong root cause analysis and cross-functional