Quality Engineer

Carl Zeiss X-ray Microscopy, Inc.

Dublin (OH)

On-site

USD 84,000 - 104,000

Full time

2 days ago
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Benefits offered by this job

Medical
Vision insurance
Dental insurance
401k Matching
Employee Assistance Programs
Vacation and sick pay

Job summary

ZEISS seeks a Quality Assurance Coordinator to support Change Management and document control across engineering and production teams. You will work to ensure ISO 9001 QMS and ISO 14001 EMS compliance, perform audits, and maintain accurate BOMs and master data within the MRP system.

You will collaborate with cross-functional and global teams to drive continuous quality improvements. The role is on-site in Dublin, CA, with domestic and international travel as required, offering a competitive

Qualifications

  • Mechanical, Electrical Engineering or Mechatronics Engineering degree required.
  • Experience in ISO 9001 QMS and ISO 14001 EMS preferred.
  • Ability to independently perform and lead investigations using CAPA methodologies (e.g., 8D).

Responsibilities

  • Oversee Change Management operations, including ECR/ECO/DCO/PCO.
  • Ensure documents are revision-controlled and distributed.
  • Conduct quality assessments and audits to ensure compliance with procedures.
  • Support ISO 9001 QMS and ISO 14001 EMS initiatives and audits.
  • Maintain master data in the MRP system and support NPI documentation.
  • Collaborate with global stakeholders across time zones.

Skills

Cross-functional collaboration
Capable to lead investigations (CAPA 8
Audit & quality control
Document control & revision management
Quality audits
MS Office proficiency (Excel, Outlook)

Education

Mechanical, Electrical or Mechatronics engineering degree

Tools

SolidWorks
MRP database

Job description

About Us:

How many companies can say they've been in business for over 179 years?!

Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!


Location/Region: Dublin, CA

What's the role?

This job role is responsible for supporting quality assurance efforts across business operations to ensure adherence to standards and enhance overall performance. They conduct quality assessments, analyze process efficiencies, and implement best practices to identify and resolve quality issues. They collaborate with cross-functional teams to support quality excellence, foster a culture of quality awareness, and align quality initiatives with organizational goals.


Sound Interesting?

Here's what you'll do:


  • Oversee daily Change Management operations, including Engineering Change Requests (ECR), Engineering Change Orders (ECO), Document Change Orders (DCO), and Prototype Change Orders (PCO).

  • Oversee daily operations related to the Change Management process, including Engineering Change Requests (ECR), Engineering Change Orders (ECO), Document Change Orders (DCO), and Prototype Change Orders (PCO).

  • Evaluate engineering and process documents, recommending modifications through consultations with appropriate stakeholders before they enter the Change Management workflow.

  • Ensure all documents are accurately revision-controlled and properly distributed.

  • Keep document control records and documents up to date in accordance with ISO 9001 QMS standards and ISO 14001 EMS.

  • Perform audits of Quality logs and storage folders/databases to verify compliance with established procedures and report findings.

  • Engage in and contribute to processes, including but not limited to View Extension (VE), Waiver, Scrap, Inspection, and Cost of Poor Quality (COPQ), as required by business needs.

  • Support and participate in ISO 9001 QMS management and compliance initiatives and audits.

  • Develop and monitor key performance indicators in collaboration with the reporting manager for document control processes, covering stages from analysis and approval to implementation.

  • Manage and update master data, including item master and bills of materials, within the MRP database.

  • Implement changes to document control systems, such as PDM or other databases in use.

  • Assist in new product introduction projects by supporting the creation of necessary documentation.

  • Address and support internal and external customer/supplier inquiries, including investigations, inspection of incoming parts, FAI parts, field return parts, and stock quality verification/inspection.

  • Lead and support continuous improvement efforts to boost efficiency and effectiveness, aligned with business priorities.

  • Assist and lead as needed in Supplier Quality, Internal Quality, Customer Quality, Calibration, and Root Cause Analysis activities, using CAPA, CAR, and SCAR.

  • Execute projects and activities as assigned by the department manager to fulfill departmental objectives and goals.

  • Participate in and lead projects as needed to implement the Quality Management System (QMS) and other quality-related ERP initiatives for System Landscape Modernization.

  • Provide support to the XRM facility in Dublin as well as its subsidiary locations worldwide.


Do you qualify?


  • Mechanical, Electrical Engineering or Mechatronics Engineering degree.

  • 5 years of work experience preferred

  • Strong computer skills with proficiency in MS Office, including Excel and Outlook.

  • Ability to evaluate mechanical and technical drawings and technical documents.

  • Understanding of instrument bill of materials (BOM) structures (preferred).

  • Proficiency with SolidWorks (preferred) to evaluate 2D and 3D CAD files.

  • Capacity to learn new software applications and processes within short duration.

  • Knowledge of ISO 9001 QMS and ISO 14001 EMS (preferred).

  • Ability to independently perform and lead investigations using CAPA methodologies (e.g., 8D).

  • Excellent oral and written communication skills; strong collaboration abilities.

  • Ability to work independently and contribute effectively to a team with limited guidance.

  • Adaptable to fast-paced, evolving demands of a growing high-tech company and being available throughout the week based on Departmental and business needs.

  • Work across different time zones with global stakeholders.

  • This is an on-site position.


Travel Requirements


  • Able to travel domestically and internationally, individually or in groups, for visits to customers, suppliers, and other Carl Zeiss facilities as required based on departmental and business needs.


The annual pay range for this position is $84,000 - $104,000


The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.


This position is also eligible for a performance bonus or sales commissions. ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.


We have amazing benefits to support you as an employee at ZEISS!


  • Medical

  • Vision

  • Dental

  • 401k Matching

  • Employee Assistance Programs

  • Vacation and sick pay

  • The list goes on!


The above is intended to describe the general content of and requirements for this job. It is not to be construed as an exhaustive statement of requirements, duties, or responsibilities. The Company reserves the right to interpret, amend, or otherwise modify, in whole or in part, any job description at any time, at its sole discretion.


Your ZEISS Recruiting Team: Jo Anne Mittelman


Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).

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