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Quality Assurance Engineer

2 months ago


Bethlehem, Pennsylvania, United States ABEC Inc Full time
Job Overview

The Quality Engineer plays a pivotal role in supporting Quality Management by implementing comprehensive operational procedures and processes that align with the overall Quality Assurance strategy of ABEC Inc. This position is integral to fostering quality enhancement across the production floor and within team dynamics, contributing as a key member of cross-functional teams focused on achieving specific objectives.

Key Responsibilities

The Quality Engineer will:

  • Analyze defect data from multiple sources to identify and prioritize critical issues for resolution, ensuring a commitment to zero defects.
  • Facilitate root cause analysis and problem-solving initiatives within the team, utilizing approved methodologies.
  • Establish defect detection criteria for monitoring during the assembly process.
  • Track ongoing defect resolution efforts and ensure that all products meet customer specifications with the utmost quality standards while fulfilling the company's performance goals.
Essential Duties

In this role, you will also:

  • Support and uphold the ABEC Quality program.
  • Ensure adherence to ABEC Standard Operating Procedures (SOPs).
  • Participate in internal and vendor audits as required.
  • Engage in Factory Acceptance Testing (FAT) and Installation Qualification/Operational Qualification (IQ/OQ) activities as assigned.
  • Coordinate Corrective and Preventive Action (CAPA) activities, including root cause analysis and both short- and long-term corrective measures.
  • Lead Continuous Improvement initiatives as designated.
  • Review and manage Engineering Change Notices (ECNs).
  • Maintain documentation within ABEC archives and support new product development efforts.
  • Adhere to all safety regulations and policies.
  • Travel as necessary for business requirements.
  • Actively identify and promote Continuous Improvement (CI) opportunities.
Qualifications

To be successful in this role, candidates should possess:

  • A Bachelor's Degree in Chemical, Mechanical, or Electrical Engineering is preferred.
  • 3-5 years of relevant experience in a quality-focused role.
  • Familiarity with cGMP, ISO 9000 standards, Six Sigma methodologies, and Certified Quality Engineer (CQE) principles.
  • Strong interpersonal and analytical skills, with an emphasis on problem-solving.
  • Excellent written and verbal communication abilities.
  • A detail-oriented mindset with effective prioritization skills.
  • Capability to manage multiple tasks efficiently.
  • Proficiency in Microsoft Office applications, particularly Outlook, Word, and Excel.
  • Experience in implementing Continuous Improvement (CI) practices is advantageous.
  • Prior exposure to Lean/Six Sigma principles is a plus.