Quality Engineer – Process Improvement (Escondido Onsite)

Arch-Medical-Solutions; Escondido (CA); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

PTO

Benefits

Job summary

ARCH Global Precision in Escondido, CA is seeking an experienced Quality Engineer to join our Quality team. This role focuses on customer satisfaction, reducing scrap, and driving continuous improvement across product and process validations.

You will collaborate with cross-functional teams, develop quality plans, perform CAPA investigations, and lead audits to uphold ISO 13485 and FDA 21 CFR Part 820 requirements.

Qualifications

• Bachelor's degree in Manufacturing/Quality Engineering or related field.
• 3+ years quality engineering experience in manufacturing.
• Strong knowledge of quality systems, methodologies, and problem-solving tools.
• Experience with CAPA programs, PFMEA, GR&R, SPC, and process capability studies.

Responsibilities

• Develop and maintain quality plans, inspection plans, control plans, work instructions, and PFMEAs.
• Support new product introductions, product revisions, and process development activities.
• Lead product qualifications, validations, and change control processes.
• Collaborate with Engineering to review drawings and ensure customer requirements are defined.

Skills

Quality systems

CAPA programs

GR&R

PFMEA

SPC

ISO 13485

FDA 21 CFR 820

Communication skills

MS Office

Education

Bachelor's degree in Manufacturing Engineering, Quality Engineering, or related

Tools

Minitab

CMMs

Keyence

Vertex

Job description

ARCH Global Precision in Escondido, CA is seeking an experienced Quality Engineer to join our Quality team. This role focuses on customer satisfaction, reducing scrap, and driving continuous improvement across product and process validations.

You will collaborate with cross-functional teams, develop quality plans, perform CAPA investigations, and lead audits to uphold ISO 13485 and FDA 21 CFR Part 820 requirements.