Quality Assurance Engineer

2 weeks ago

Bethlehem, Pennsylvania, United States ABEC Full time
Job Overview

This is a full-time, onsite position.

Position Overview:

The Quality Assurance Engineer collaborates with Quality Management to execute company-wide operational protocols and processes that align with the overarching Quality Assurance strategy. This role is pivotal in fostering quality enhancements across the production floor and within a collaborative team framework, contributing as a member of cross-functional teams focused on achieving specific objectives.

The Quality Assurance Engineer will evaluate and present defect data from multiple sources to prioritize critical issues for resolution, ensuring the goal of zero defects. This role will lead root cause analysis and problem-solving initiatives within the team, utilizing approved problem-solving methodologies. The engineer will establish defect detection criteria for teams to monitor during the assembly process. Additionally, they will track defects during resolution efforts and ensure that all products manufactured meet customer specifications with the utmost quality, while also fulfilling the company's performance targets.

Key Responsibilities:

· Uphold and enhance the ABEC Quality program.

· Ensure adherence to ABEC Standard Operating Procedures (SOPs).

· Support and uphold ABEC quality standards and guidelines.

· Engage in internal and supplier audits as required.

· Participate in Factory Acceptance Testing (FAT) and Installation Qualification/Operational Qualification (IQ/OQ) activities as assigned.

· Coordinate assigned Corrective and Preventive Action (CAPA) initiatives, including root cause analysis and both short- and long-term corrective actions.

· Facilitate assigned Continuous Improvement (CI) projects.

· Review, authorize, and manage Engineering Change Notices (ECNs).

· Complete Document Control and Change Management tasks as directed.

· Maintain documentation within ABEC archives.

· Assist in new product development efforts as directed.

· Execute additional tasks as assigned (Quality, Project, Product Development, etc.).

· Adhere to all safety regulations and policies.

· Execute other responsibilities as assigned.

· Will actively identify and promote Continuous Improvement (CI) opportunities.

Qualifications:

  • Bachelor's Degree in Chemical, Mechanical, or Electrical Engineering preferred.
  • 3-5 years of relevant experience in a quality-related field.
  • Familiarity with cGMP or ISO 9000 standards, Six Sigma methodologies, and Certified Quality Engineer (CQE) principles.
  • Strong interpersonal and analytical skills are essential.
  • Excellent written and verbal communication abilities.
  • Detail-oriented with strong prioritization skills.
  • Adept at multitasking.
  • Proficient in Microsoft Office Suite, particularly Outlook, Word, and Excel.
  • Experience in implementing Continuous Improvement (CI) initiatives is advantageous.
  • Prior experience with Lean/Six Sigma practices is a plus.

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