Senior Quality Engineer

About the role

Work on quality aspects of the Product/Process Development Process, ensuring compliance with regulatory requirements (ISO 13485, FDA QSR).

Responsibilities

• Develop and execute validation protocols, including Test Method Validation (TMV), Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ).
• Understand customer requirements and transfer the knowledge to the process development for higher FPY and success of existing and new projects.
• Maintain Risk Management Files, dFMEAs, pFMEAs, and Control Plans.
• Support customer calls and be the quality representative in such interactions.
• Participate in training activities including salaried and hourly employees.
• Serve as the subject matter expert for programming and validating vision-based and touch-probe CMMs (MicroVu, Keyence, Laserlinc, Zumbach).
• Work on inspection method development, qualification (TMV, Gage R&R), and statistical analysis (SPC, DOE).
• Drive automation initiatives, including electronic QMS, Quality 4.0, and electronic SPC implementation.
• Assist in fixture design and work-holding solutions to optimize measurement processes.
• Provide training on automated measurement systems and GD&T interpretation.
• Investigate customer complaints and NCRs, conduct root cause analysis, and implement corrective/preventive actions (CAPA).
• Act as a consultant for quality system processes, including supplier quality, internal audits, environmental monitoring, and training.
• Support process improvements through Lean and Six Sigma methodologies.
• Make data-driven decisions and coordinate reporting using statistical tools (Minitab, Excel).
• Ensure compliance with regulatory, customer, and internal quality requirements.
• Develop site wide KPIs with modern data analytics tools like PowerBI.

Requirements

• Bachelor's degree, or foreign equivalent, in Mechanical or Industrial Engineering, or a related field and Five (5) years of experience as a Quality Engineer, Continuous Improvement Engineer, Manufacturing Engineer, Industrial Engineer, or related occupation.
• Employer will accept a Master's degree, or foreign equivalent, in Mechanical or Industrial Engineering, or a related field plus three (3) years of experience as a Quality Engineer, Continuous Improvement Engineer, Manufacturing Engineer, Industrial Engineer, or related occupation.
• Must have three (3) years demonstrated experience in each of the following: Completing lean-six sigma projects resulting in overall improvement of product quality, cost reduction and customer satisfaction.
• Must have one (1) year demonstrated experience in each of the following:
  • Working with Automated Measurement Systems like vision systems, CMMs etc.
  • Working with Statistical Process Control (SPC).
  • Making quality scrap reduction and continuous improvement.
  • Working with Data Analytics tools including PowerBI, Excel VBA, and Pivot Tables.
  • Implementing and working with an Electronic Quality Management (eQMS) System.
• Must have six (6) months demonstrated experience in each of the following: Implementing and tracking Cost of Poor Quality (COPQ) Metrics and successfully reducing such costs.