Quality Management Systems Analyst

Job Overview

The Quality Management Systems Analyst is responsible to ensure organizational procedures and processes align with regulatory, TE, customer, and local requirements. This position is critical to building, enabling, and sustaining systems that promote a strong quality culture and continuous improvement. This position reports to the Quality Manager.

Please note: This position may involve working with technical data, technology, software/source code, hardware or other items (collectively “items) subject to U.S. and non-U.S. export control laws and regulations.  Under these regulations, it may be necessary for TE to verify a candidate’s national origin and/or citizenship status to determine whether a U.S. or other government export license is required prior to releasing its technologies to the candidate.  If TE determines that TE will require a license or will be prohibited by applicable laws from providing the candidate with items necessary for the performance of this position, then TE expressly reserves the right to either a) make an offer of employment contingent upon TE receiving required export licenses from the appropriate government agency, b) consider the candidate for a different position that is not subject to such restrictions, on whatever terms and conditions TE shall establish in its sole discretion, or c) decline to move forward with the candidate’s application.

Short Description

Primary Responsibilities:

• Ensure all elements of the QMS meet or exceed the applicable ISO/AS standards and other relevant regulations
• Manage site procedures, specifications and other controlled documents ensuring compliance with regulatory, TE and local procedures and requirements (including management of Change Control, and Document/Record Control)
• Manage the Internal Audit process and conduct audits as needed (AS9100, FAA, customer-required, etc)
• Provide direct support external audits (e.g., ISO, AS, DLA, customer); co-lead audits with site leadership; organize plan and communicate audit requirements internally and externally as required
• Manage and ensure closure of internal and external audit findings
• Support Management Review process, organize meetings, ensure compliance with requirements
• Maintain records according to TE Corporate Records Retention Policy and customer requirements
• Support Quality and Company objectives and goals
• Support training and expertise in the above listed areas.

What your background should look like:

• Bachelor’s degree in Engineering, Quality Management/related field, or 2+ years Quality Systems experience
• Highly organized and able to clearly communicate requirements, and partner with stakeholders to implement and/or improve processes
• Solid understanding of the following bodies of knowledge:
  • ISO 9001:2015 required
  • AS9100D preferred, consideration given for FDA CFR 210/211 or ISO 13485:2016
  • IPC 610, JSTD (preferred)
• Understanding of the key quality terms, definition, facts, methods, and principles
• Ability to evaluate proposed ideas, solutions, corrections compared to specifications
• Advanced computer experience with writing and editing documentation
• Read and understand descriptions, reports, regulations, instructions, technical documents, etc.
• Ability to breakdown and analyze information and recognize their relationship to one another
• Ability to communicate complex issues and solutions to cross-functional teams verbally and in writing

Competencies