Demo

Quality Engineer

Katalyst Healthcares and Life Sciences
Birmingham, AL Full Time
POSTED ON 2/19/2025
AVAILABLE BEFORE 5/19/2025

Responsibilities :

  • Assists in the implementation of, and compliance with, ISO standards.
  • Assists in identifying customer-required quality compliance specifications and translating them into effective procedures, instructions, and training material.
  • Develops and maintains quality procedures and instructions for engineering, material testing, and design and development projects.
  • Maintains a controlled QMS document library.
  • Supports Corrective Action efforts for problem identification, improvement, and prevention.
  • Prepares material used to evaluate the effectiveness of the quality management system in support of management review meetings and in other.
  • settings.
  • Provides support for customer representatives regarding quality issues.
  • Assist with the development and implementation of the overall quality management system to AS9100 and create inspection plans and processes for AS9102 compliance.
  • Participate in the development of and utilize key performance indicators (KPI's) to achieve Quality goals.
  • Works with suppliers to resolve or improve quality issues and to implement effective corrective action.
  • Works with support service stakeholders, including Procurement, IT, Human Resources, Contract Administration, and Facilities to ensure a fully compliant management system environment.
  • Supports engineers and technical staff in design and process validations, process control, process training, process improvement, and risk management.
  • Coordinates process steps, standards and requirements, and infrastructure to enhance the existing quality management system.
  • Other quality related responsibilities assigned by management.

Requirements :

  • Bachelor's degree or higher in STEM focused area (science, technology, engineering, math) or other quality or management related field.
  • Must be able to obtain / maintain DoD clearance.
  • Experience with Quality Management processes in an environment compliant with ISO9001, AS / IA9100, or ISO standards.
  • Working knowledge of desktop applications including MS Outlook, Word, Excel, and PowerPoint
  • Excellent written and verbal communication skills.
  • Good problem-solving abilities using systematic, logical, and sequential approaches.
  • Self-motivation to take the initiative to complete tasks.
  • Ability to work cooperatively in a team environment to reach common results and goals.
  • ISO 19011 : 2018 Lead Auditor Certification.
  • Sense of Urgency - Takes initiative to resolve problems / issues.
  • Individual Accountability - Takes responsibility and consistently delivers on commitments.
  • Builds relationships - Continuously fosters positive working relationships by developing win-win solutions.
  • Analytical - Makes decisions to solve problems by using sound judgment.
  • Sets High Standards - Demands excellence by continuously raising the performance bar.
  • Attention to Detail - Utilizes established monitoring systems, records data accurately and in a timely manner, andensures accuracy of data.
  • Communication - Effectively communicates verbally with others and in writing.
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