Supplier Quality Engineer

Insight Global; Irvine (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Insight Global is seeking a Supplier Quality Engineer to oversee supplier qualification, process validation, and product quality continuity during manufacturing transfers.

The role requires collaboration with Regulatory Affairs, Manufacturing Engineering, and Operations to mitigate risk and maintain compliant medical devices throughout the transfer lifecycle.

Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• 4+ years in Supplier Quality/Quality/Manufacturing Eng within medical devices or regulated industry.
• Experience supporting manufacturing transfers (site transfers or product transfers).

Responsibilities

• Execute supplier qualification and auditing activities.
• Lead process validation efforts (IQ/OQ/PQ) for transfers.
• Support manufacturing/site transfers to ensure uninterrupted supply of compliant devices.
• Collaborate cross-functionally with Regulatory, Manufacturing Engineering, and Operations teams.
• Apply risk management (ISO 14971) and CAPA/NCR analysis.

Skills

Supplier qualification/auditing

Process validation IQ/OQ/PQ

CAPA/NCR/root cause analysis

Risk management ISO 14971

PPAP/FMEA/Control plans

Statistical analysis tools

FDA QSR/ISO 13485 knowledge

Education

Bachelor’s degree in Engineering or related field

Tools

IQ/OQ/PQ validation

CAPA management

Control plans

Job description

Job Description

The Supplier Quality Engineer will play a critical role in executing supplier-related quality activities associated with the transfer of manufacturing operations between sites. This individual will ensure supplier qualification, process validation, and product quality continuity are maintained in alignment with FDA, ISO 13485, and internal quality standards.The role requires cross-functional collaboration with Supplier Quality, Manufacturing Engineering, Regulatory Affairs, and Operations teams to mitigate risk and ensure uninterrupted supply of compliant medical devices throughout the transfer lifecycle.

Skills and Requirements

• Bachelor’s degree in Engineering or a related technical field (e.g., Mechanical, Biomedical, Industrial).
• 4+ years of experience in Supplier Quality, Quality Engineering, or Manufacturing Engineering within the medical device or regulated industry.
• Experience supporting manufacturing transfers, site transfers, or product/process transfers.
• Strong knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and GMP requirements.
• Hands-on experience with:Supplier qualification and auditingProcess validation (IQ/OQ/PQ)CAPA, NCR, and root cause analysis methodologiesRisk management (ISO 14971 preferred)Familiarity with PPAP, FMEA, control plans, and statistical analysis tools.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [e-mail].