Quality Engineer - Validation & Continuous Improvement

Careers With Westfall Technik; Union (CA); On-site; USD 115,000 - 125,000; Full time

Benefits offered by this job

Paid holidays

Sick pay

Vacation pay

401K with employer match

Medical Insurance

Dental Insurance

Vision Insurance

Life and AD&D insurance

Short/Long term disability

Parental leave

Job summary

Westfall Technik is seeking a Quality Engineer to join our manufacturing team in the USA. The role focuses on validating products, processes and systems to meet internal quality standards and regulatory requirements.

You will lead validation activities, inspection planning, metrology, NCMR review and act as the primary liaison for customer quality concerns. You will also support QA compliance, audits, CAPA activities, data analysis and continuous improvement initiatives to ensure product

Qualifications

• Bachelor's degree in engineering or equivalent required.
• 3–5 years of quality engineering in a manufacturing environment preferred.
• Strong knowledge of ISO 9001, ISO 13485 and IATF 16949 standards.

Responsibilities

• Validate equipment, processes and products including IQ/OQ/PQ and validation master plans.
• Design and implement inspection criteria and control plans for incoming, in-process and final products.
• Oversee calibration, metrology systems, MSA and Gage R&R activities.
• Review and disposition Non Conforming Material Reports (NCMRs) and implement containment and corrective actions.
• Serve as main point of contact for customer quality concerns and audits; provide root cause analysis and corrective actions.
• Support internal/external quality audits and maintain quality documentation (NCRs, deviation records, change control).
• Lead or support root cause investigations and CAPA using 8D, 5 Why, Fishbone.
• Collect, analyze and report quality data; generate monthly/quarterly performance reports.
• Assist supplier qualification and address supplier quality issues.
• Take on additional duties to support operations.

Skills

Validation Planning

Inspection Planning

Gage R&R

NCMR Review

Customer Interface

Education

Bachelor's degree in engineering or related field

Job description

Westfall Technik is seeking a Quality Engineer to join our manufacturing team in the USA. The role focuses on validating products, processes and systems to meet internal quality standards and regulatory requirements.

You will lead validation activities, inspection planning, metrology, NCMR review and act as the primary liaison for customer quality concerns. You will also support QA compliance, audits, CAPA activities, data analysis and continuous improvement initiatives to ensure product