Quality Engineer

ARCH•Escondido, CA

23d•$80,000 - $95,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.