Quality Engineer

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

Here at Westfall Technik we pride ourselves on being a fast growing Plastic Injection Manufacturing Company in the USA and soon Globally While many companies outsource their work we believe in keeping our jobs in the US We currently support over 1100 employees across 11 facilities in the US and we are still growing At our Delta Yimin Technologies Inc we invest in our people Our overall success is largely contributed to our employees skills and talents that have been impactful and essential to the growth of our business Here youll get the opportunity to test your knowledge and skills and become a critical player within Westfall We want you to view your time at Westfall as an investment to your future We are currently seeking a Quality Engineer with the below qualifications Professional Attributes The Quality Engineer is responsible for ensuring that products processes and systems meet internal quality standards customer requirements and applicable regulatory guidelines This role focuses on validation planning inspection control metrology systems and cross functional quality support The Quality Engineer also serves as the main quality point of contact for customer concerns and is responsible for leading the review and disposition of Non Conforming Material Reports NCMRs The position supports product integrity regulatory compliance and continuous improvement across the manufacturing operation

Desired Skills and Experience

1. 1 Validation Planning & Execution Develop review and execute equipment process and product validation protocols including IQ Installation Qualification OQ Operational Qualification and PQ Performance Qualification Define and manage validation master plans validation schedules and test methods in alignment with engineering and regulatory requirements Coordinate with cross functional teams to validate new tooling equipment product designs and process changes Document and maintain all validation records traceability matrices and summary reports in accordance with the companys Quality Management System QMS
2. 2 Inspection Planning & Execution Design and implement effective inspection strategies for incoming materials in process production and final product release Create and maintain inspection criteria control plans and visual aids based on product specifications and engineering drawings including GD&T Conduct First Article Inspections FAI capability studies and inspection audits to ensure compliance with defined quality standards Train inspectors and production personnel on proper inspection procedures and defect identification
3. 3 Metrology & Measurement Systems Oversee calibration and maintenance of all measurement and inspection equipment ensuring traceability to nationalinternational standards Conduct Measurement Systems Analysis MSA including Gage Repeatability & Reproducibility Gage R&R to validate the reliability of measurement tools Recommend and implement metrology best practices including appropriate inspection techniques for complex geometries and tolerances
4. 4 NCMR Review & Disposition Review and evaluate Non Conforming Material Reports NCMRs from production inspection or incoming material Lead disposition decisions use as is rework return to vendor or scrap in collaboration with Engineering Manufacturing and Supply Chain Document actions taken and ensure appropriate containment and corrective actions are implemented
5. 5 Customer Interface & Communication Act as the main point of contact for customer quality concerns audits and issue resolution Respond to customer complaints and initiate root cause analysis and corrective actions 8D 5 Why Fishbone etc Provide timely updates and reports to customers regarding product quality non conformance investigations and corrective actions
6. 6 Quality Assurance & Compliance Ensure compliance with internal procedures customer specific requirements and industry standards ISO 9001 ISO 13485 IATF 16949 etc Participate in internal and external quality audits and support audit preparedness and corrective actions Maintain documentation such as non conformance reports NCRs deviation records and change control documentation
7. 7 Problem Solving & Continuous Improvement Lead or support root cause investigations and the implementation of Corrective and Preventive Actions CAPA using structured problem solving tools such as 8D 5 Why and Fishbone Analysis Collaborate with engineering manufacturing and supply chain to reduce scrap rework and customer complaints Participate in Lean Six Sigma and Kaizen initiatives to optimize process capability and efficiency
8. 8 Data Analysis & Reporting Collect analyze and present quality data including inspection results validation outcomes calibration status and nonconformance trends Generate monthlyquarterly quality performance reports for internal reviews and customer reporting Utilize statistical tools SPC Minitab Excel etc to interpret data and drive decisions
9. 9 Supplier Quality as needed Support supplier qualification processes including review of supplier validation and inspection plans Evaluate supplier performance through incoming inspection results and nonconformance trends Work with suppliers to address quality issues and support improvement actions
10. 10 Other Duties as Assigned Take on additional responsibilities as needed to support the team and meet operational priorities Specific Skill Set Communication Strong verbal and written communication skills to interface with teams and customers Presentation Excellent analytical skills to identify root causes and recommend corrective actions System Proficient in quality management systems QMS ERP systems and Microsoft Office Suite Analytics Familiar with statistical tools SPC MSA FMEA control plans and Six Sigma methodologies Exposure Bachelors degree in engineering Mechanical Industrial Manufacturing or equivalent 35 years of experience in quality engineering in a manufacturing environment In depth knowledge of validation methodologies IQOQPQ inspection planning and metrology systems Proficiency in interpreting technical drawings GD&T and control plans Experience in using quality tools and statistical analysis techniques SPC MSA FMEA Gage R&R Working knowledge of ISO 9001 ISO 13485 IATF 16949 or other relevant standards Strong written and verbal communication skills Experience with quality software tools eg Minitab QMS platforms is a plus

Specific Skill Set

Communication Strong verbal and written communication skills to interface with teams and customers Presentation Excellent analytical skills to identify root causes and recommend corrective actions System Proficient in quality management systems QMS ERP systems and Microsoft Office Suite Analytics Familiar with statistical tools SPC MSA FMEA control plans and Six Sigma methodologies Exposure Bachelors degree in engineering Mechanical Industrial Manufacturing or equivalent 35 years of experience in quality engineering in a manufacturing environment In depth knowledge of validation methodologies IQOQPQ inspection planning and metrology systems Proficiency in interpreting technical drawings GD&T and control plans Experience in using quality tools and statistical analysis techniques SPC MSA FMEA Gage R&R Working knowledge of ISO 9001 ISO 13485 IATF 16949 or other relevant standards Strong written and verbal communication skills Experience with quality software tools eg Minitab QMS platforms is a plus

WORK ENVIRONMENT

The work environment is usually in an office within a manufacturing facility with low to moderate noise level The work environment characteristics described here are e of those an employee encounters while performing the essential functions of this job Ability to work well with others one on one remote via video and phone Ability to work independently Westfall Technik is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race color national origin ancestry sex gender gender identity gender expression pregnancy childbirth or related medical conditions religious creed physical disability mental disability age for individuals age 40 and over medical condition as defined by state law for example cancer or genetic characteristics or HIVAIDS marital status military and veteran status sexual orientation genetic information citizenship status or any other characteristic protected by federal state or local law Our management team is dedicated to this policy with respect to recruitment hiring placement promotion transfer training compensation benefits employee activities and general treatment during employment

What Youll Love About Us

Salary 120000 Based on education and experience11 Paid Holidays Sick Pay Vacation Pay401K Plus Employer MatchMedical Dental Vision Company Sponsored Life and AD&D Short and Long Term Disability Paid Parental Leave and More

We are committed to creating a diverse work environment and proud to be an equal opportunity employer All qualified applicants will receive consideration for employment without regard to race color region gender gender identity or expression sexual orientation national origin genetics disability age veteran status or any other basis protected by law