Quality Systems Engineer

Socket.dev

Hudson (NH)

On-site

USD 90,000 - 120,000

Full time

6 days ago
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Job summary

onsemi is seeking a Quality Systems Engineer at our Hudson, NH site to develop, implement, maintain, and continuously improve the Quality Management System. You will partner with Manufacturing, Engineering, Supply Chain and Operations to drive quality excellence and compliance.

The role includes leading audits, CAPA, data analysis, and mentoring teams on QMS adherence to reduce risk and drive measurable improvements across the organization.

Qualifications

  • Bachelor's degree in Engineering, Quality Management, Manufacturing Engineering, Industrial Engineering, or a related technical field.
  • 3+ years of experience in a quality engineering, quality systems, or manufacturing quality role.
  • Experience maintaining Quality Management Systems within a manufacturing environment. (semiconductor preferred)
  • Knowledge of quality standards such as ISO 9001 and IATF 16949.
  • Experience conducting audits and managing corrective action programs.
  • Strong problem-solving and root cause analysis skills.
  • Proficiency with Microsoft Office applications and quality management software.
  • Excellent written and verbal communication skills.
  • Ability to execute complex projects, and self-direct and prioritize work

Responsibilities

  • Maintain and continuously improve the Quality Management System in accordance with applicable standards and regulations (e.g., ISO 9001, IATF 16949, RBA as applicable).
  • Develop, review, and update quality procedures, work instructions, and system documentation.
  • Coach QMS process owners on how to identify and close gaps to customer, regulatory, and industry requirements.
  • Monitor QMS effectiveness through internal audits, data analysis, and performance metrics.
  • Plan, coordinate, and conduct internal audits.
  • Support customer, registrar, and regulatory audits.
  • Track audit findings and ensure timely closure of corrective actions.
  • Ensure compliance with customer requirements, industry standards, and regulatory expectations.
  • Lead root cause investigations using methodologies such as 8D, Fishbone, 5 Whys, and FMEA.
  • Facilitate corrective and preventive action activities across functional teams.
  • Verify effectiveness of implemented solutions and ensure sustainable process improvements.
  • Analyze quality data and identify opportunities for continuous improvement.
  • Collaborate with manufacturing and engineering teams to reduce defects, scrap, rework, and customer complaints.
  • Support Lean Manufacturing, Six Sigma, and continuous improvement initiatives.
  • Drive standardization and best practices internally and to onsemi manufacturing locations.
  • Maintain quality performance dashboards and KPI reporting.
  • Monitor trends related to nonconforming material, internal defects, supplier quality, and customer complaints.
  • Present findings and recommendations to leadership and cross-functional teams.
  • Train employees on quality system requirements, procedures, and best practices.
  • Provide guidance to manufacturing and support teams regarding quality standards and compliance requirements.
  • Promote a culture of quality throughout the organization.

Skills

Problem solving
Root cause analysis
Communication skills
Attention to detail
Project management
Cross-functional collaboration
Analytical thinking

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office
ERP systems
MES systems
QMS software

Job description

onsemi is seeking a Quality Systems Engineer in our Hudson, NH site. The Quality Systems Engineer is responsible for developing, implementing, maintaining, and continuously improving the Quality Management System (QMS) to ensure compliance with customer, regulatory, and industry requirements. This role partners with Manufacturing, Engineering, Supply Chain, and Operations teams to drive quality excellence, process improvements, risk reduction, and compliance initiatives. The Quality Systems Engineer serves as a key resource for audits, corrective and preventive actions (CAPA), Coaching teams on QMS requirement adherence , and quality metrics.


Responsibilities

Quality Management System (QMS)



  • Maintain and continuously improve the Quality Management System in accordance with applicable standards and regulations (e.g., ISO 9001, IATF 16949, RBA as applicable).

  • Develop, review, and update quality procedures, work instructions, and system documentation.

  • Coach QMS process owners on how to identify and close gaps to customer, regulatory, and industry requirements.

  • Monitor QMS effectiveness through internal audits, data analysis, and performance metrics.


Audits & Compliance



  • Plan, coordinate, and conduct internal audits.

  • Support customer, registrar, and regulatory audits.

  • Track audit findings and ensure timely closure of corrective actions.

  • Ensure compliance with customer requirements, industry standards, and regulatory expectations.


Corrective and Preventive Actions (CAPA)



  • Lead root cause investigations using methodologies such as 8D, Fishbone, 5 Whys, and Failure Mode and Effects Analysis (FMEA).

  • Facilitate corrective and preventive action activities across functional teams.

  • Verify effectiveness of implemented solutions and ensure sustainable process improvements.


Process Improvement



  • Analyze quality data and identify opportunities for continuous improvement.

  • Collaborate with manufacturing and engineering teams to reduce defects, scrap, rework, and customer complaints.

  • Support Lean Manufacturing, Six Sigma, and continuous improvement initiatives.

  • Drive standardization and best practices internally and to onsemi manufacturing locations.


Quality Metrics & Reporting



  • Maintain quality performance dashboards and KPI reporting.

  • Monitor trends related to nonconforming material, internal defects, supplier quality, and customer complaints.

  • Present findings and recommendations to leadership and cross-functional teams.


Training & Support



  • Train employees on quality system requirements, procedures, and best practices.

  • Provide guidance to manufacturing and support teams regarding quality standards and compliance requirements.

  • Promote a culture of quality throughout the organization.


Qualifications


  • Bachelor's degree in Engineering, Quality Management, Manufacturing Engineering, Industrial Engineering, or a related technical field.

  • 3+ years of experience in a quality engineering, quality systems, or manufacturing quality role.

  • Experience maintaining Quality Management Systems within a manufacturing environment. (semiconductor preferred)

  • Knowledge of quality standards such as ISO 9001 and IATF 16949.

  • Experience conducting audits and managing corrective action programs.

  • Strong problem-solving and root cause analysis skills.

  • Proficiency with Microsoft Office applications and quality management software.

  • Excellent written and verbal communication skills.

  • Ability to execute complex projects, and self-direct and prioritize work


Preferred Qualifications



  • ISO 9001 / IATF Lead Auditor Certifications

  • Lean Six Sigma Green Belt or Black Belt certification.

  • Experience with statistical analysis, SPC, MSA, and capability studies.

  • Experience working with ERP, MES, or electronic QMS systems.

  • Experience working with Control Plans and FMEA methodologies.


Key Competencies



  • Continuous Improvement Mindset

  • Analytical and Critical Thinking

  • Attention to Detail

  • Regulatory and Standards Compliance

  • Project Management

  • Process Optimization

  • Cross-Functional Collaboration

  • Effective Communication

  • Problem Solving and Decision-Making


Working Conditions



  • Manufacturing and office environment.

  • Routine plant-floor interaction and occasional travel for audit activities.

  • Ability to observe production processes and conduct on-site audits.


Success Measures



  • QMS audit performance and compliance results.

  • Reduction in quality defects, scrap, and rework costs.

  • Timely closure of corrective actions and audit findings.

  • Improved customer satisfaction and quality performance metrics.

  • Successful implementation of continuous improvement initiatives.


onsemi(Nasdaq: ON) is driving disruptive innovations to help build a better future. With a focus on automotive and industrial end-markets, the company is accelerating change in megatrends such as vehicle electrification and safety, sustainable energy grids, industrial automation, and 5G and cloud infrastructure. With a highly differentiated and innovative product portfolio, onsemi creates intelligent power and sensing technologies that solve the world’s most complex challenges and leads the way in creating a safer, cleaner, and smarter world.


More details about our company benefits can be found here:


https://www.onsemi.com/careers/career-benefits


We are committed to sourcing, attracting, and hiring high-performance innovators, while providing all candidates a positive recruitment experience that builds our brand as a great place to work.


onsemiis an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, ancestry, national origin, age, marital status, pregnancy, sex, sexual orientation, physical or mental disability, medical condition, genetic information, military or veteran status, gender identity, gender expression, or any other protected category under applicable federal, state, or local laws.


If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or is limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Talent.acquisition@onsemi.com for assistance.

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