Quality Engineer

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

Department: Quality
Reports To: Quality Manager

Salary Range: $85-$105,000 depending on experience

This role is onsite in Escondido, CA.

Why Join Us?

• Gain exposure to new technologies, automated inspection systems, and cross-functional leadership opportunities
• Competitive pay, PTO, and benefits
• Strong team culture focused on quality and improvement

About Us

ARCH Global Precision manufactures high-precision components and engineered solutions for customers in demanding industries. Through advanced manufacturing capabilities, technical expertise, and a strong commitment to quality, we help our customers bring innovative products to market with confidence.

About the Role

We are seeking an experienced Quality Engineer to join our Quality team. This position plays a critical role in ensuring customer satisfaction, reducing internal scrap, driving continuous improvement initiatives, and supporting product and process validations. The ideal candidate is detail-oriented, analytical, and thrives in a fast-paced manufacturing environment while collaborating effectively with cross-functional teams.

Key Responsibilities

As a Quality Engineer, you will:

• Develop and maintain quality plans, inspection plans, control plans, work instructions, and PFMEAs.
• Support new product introductions, product revisions, and process development activities.
• Participate in product qualifications, validations, and change control processes.
• Collaborate with Engineering to review drawings and ensure customer requirements are clearly defined and understood.
• Conduct measurement system analyses including GR&R studies and establish effective inspection methods.
• Lead or support Material Review Board (MRB) activities and nonconformance investigations.
• Manage customer complaints, CAPAs, NCMRs, and corrective action activities.
• Utilize quality tools such as Root Cause Analysis, FMEA, Risk Analysis, SPC, and 8D problem-solving methodologies.
• Perform internal audits and support external audits as required.
• Analyze process data and conduct process capability studies to drive continuous improvement.
• Train employees on quality requirements, inspection methods, and metrology practices.
• Support equipment validations and qualification activities in partnership with Maintenance, IT, and Operations teams.
• Drive initiatives to improve manufacturing quality, efficiency, and customer satisfaction.

Required Qualifications

• Bachelor's degree in Manufacturing Engineering, Quality Engineering, or a related technical discipline, or an equivalent combination of education and experience.
• Minimum of 3 years of quality engineering experience in a manufacturing environment.
• Strong knowledge of quality systems, methodologies, and problem-solving tools.
• Experience with CAPA programs, process capability studies, GR&R, PFMEA, and SPC.
• Knowledge of ISO standards, preferably ISO 13485, and FDA regulations including 21 CFR Part 820.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office applications including Word, Excel, Outlook, and PowerPoint.
• Ability to work effectively in a cross-functional team environment.

Preferred Qualifications

• ASQ Certification (CQE, CSQE, Six Sigma Black Belt, Lean, or equivalent).
• Strong GD&T knowledge and experience.
• Experience with Minitab.
• Experience using automated inspection equipment such as CMMs, Keyence, Vertex, or similar systems.
• Experience developing manufacturing quality plans and driving process optimization projects.

What We're Looking For

• High energy and self-motivation.
• Strong attention to detail and accountability.
• Excellent analytical and problem-solving abilities.
• Effective interpersonal and communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Commitment to continuous improvement and operational excellence.

Physical Requirements

• Ability to sit, stand, walk, talk, and hear frequently throughout the workday.
• Ability to lift up to 20 pounds occasionally.

Equal Opportunity Employer

Additional Notes ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.