Senior Quality Engineer - Process Validation & PPAP Lead

Kelly Services; Arroyo (PR); On-site; USD 39,000 - 52,000; Full time

Benefits offered by this job

Medical, dental, vision

Telemedicine

Term life

Whole life

Accident insurance

Critical illness

Legal plan

Short-term disability

Retirement savings plan

Holiday pay

Transit spending account

Paid sick leave

Job summary

Kelly Services is seeking a Senior Quality Engineer in Arroyo, PR for an 18-month contract. The role focuses on identifying potential failure modes and developing QA practices for new product introductions and manufacturing transfers, ensuring compliance with design controls.

You will lead risk assessments, supplier qualifications, validation activities, and post-launch quality monitoring, while mentoring engineers and coordinating with internal teams to deliver compliant, high-quality products.

Qualifications

• Excellent interpersonal communication and collaborative teamwork.
• Ability to read and interpret blueprints and engineering schematics.
• Ability to analyze and correct complex process issues using independent judgment.
• Strong knowledge of validation per FDA-QSR and ISO guidelines.
• Proven ability to operate test and inspection equipment.

Responsibilities

• Evaluate process risks and implement production controls across lifecycle.
• Verify gage repeatability, reproducibility, and accuracy; address deficiencies.
• Lead supplier component qualifications and PPAP processes.
• Develop validation strategies and statistical rationale for testing.
• Ensure compliance with quality regulations and prepare for audits.
• Lead post-launch monitoring and address non-conformances.
• Coach engineers and trainees in quality systems and transfer.

Skills

Excellent interpersonal communication

Blueprint/engineering schematicReading

Independent judgment

Basic inspection techniques

Basic PC skills

Financial knowledge

Technical writing skills

Effective presentation skills

Bilingual English/Spanish

FDA-QSR ISO validation knowledge

Statistical knowledge

Job description

Kelly Services is seeking a Senior Quality Engineer in Arroyo, PR for an 18-month contract. The role focuses on identifying potential failure modes and developing QA practices for new product introductions and manufacturing transfers, ensuring compliance with design controls.

You will lead risk assessments, supplier qualifications, validation activities, and post-launch quality monitoring, while mentoring engineers and coordinating with internal teams to deliver compliant, high-quality products.