Quality Engineer II

United States·Salemmid

EngineeringQuality Engineer

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Quick Summary

Overview

The Quality Engineer II supports quality assurance activities to ensure products and processes meet established standards and regulatory requirements.

Technical Tools

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The Quality Engineer II supports quality assurance activities to ensure products and processes meet established standards and regulatory requirements. This role works under guidance to investigate issues, support continuous improvement initiatives, and help maintain compliance with the Analogic Quality Management System.

Essential Duties and Responsibilities:

Support investigation of quality issues using structured problem-solving methods (e.g., root cause analysis, 8D) with guidance from senior engineers.
Assist in implementing corrective and preventive actions (CAPA) to address product and process nonconformances.
Participate in inspection, testing, and evaluation of materials and products to ensure compliance with specifications.
Collaborate with Manufacturing, Engineering, and Supply Chain to resolve quality-related issues.
Collect and analyze quality data to support reporting and trend analysis.
Assist in maintaining quality metrics and documentation for internal and external reporting.
Support internal audits and help prepare for customer and regulatory inspections.
Participate in new product introduction (NPI) activities, including design reviews and risk assessments (e.g., FMEA).
Help maintain and improve quality procedures, work instructions, and standard operating processes.
Contribute to continuous improvement initiatives such as Lean, Six Sigma, and 5S efforts.
Respond to customer generated complaints and Supplier Corrective Action Requests (SCARS), including investigation, root cause analysis, and timely resolution.

Education, Work Experience, Skills and Competencies Requirements:

Bachelor’s degree in Engineering, Quality, or a related technical field (or equivalent experience).
5-7 years of experience in quality engineering, manufacturing, or related environment.
Basic understanding of quality tools and methodologies (e.g., CAPA, root cause analysis, SPC, FMEA).
Familiarity with ISO 9001 and/or ISO 13485 standards preferred.
Exposure to manufacturing processes, preferably electromechanical products, is a plus.
Proficiency in CAD software is desirable.
Experience with visual management tools and continuous improvement methodologies preferred.
Working knowledge of PLM systems, preferably Agile, including Deviations, ECOs, and Quality Alerts is desirable.
Strong analytical and problem-solving skills with attention to detail.
Ability to work collaboratively in cross-functional teams.
Effective written and verbal communication skills.
Proficiency in Microsoft Office (Excel, Word, PowerPoint); experience with ERP systems (e.g., SAP) is a plus.

What We Offer

We appreciate that our employees work diligently to contribute to our success as an organization. We also recognize the importance of work-life balance and therefore developed a competitive total rewards package including programs that offer employees flexibility to balance their work and life including:

9/80 work schedule – enjoy every other Friday off!
Flexible Vacation – employees can take time off as is reasonably needed
Comprehensive benefits including medical, dental, vision, life insurance and disability plans.
HRA (for PPO plan participants) /HSA (Health Savings Account for high deductible plan participants) contribution
401K with company match and immediate vesting
Continuous Education Assistance
Supportive culture that values innovation, collaboration, and excellence