Job Title: Quality Engineer I
Initiates, monitors, supports and evaluates quality system activities. Participates as a Quality Team Member in product design and manufacturing efforts, collaborates with engineering and manufacturing functions to ensure quality standards are in place. Comprehends quality engineering principles, theories, concepts, practices and techniques. Analyzes and participates in problem solving using creative and effective techniques or processes. Develop and monitor the quality systems and metrics related to the production of the product, monitoring quality metrics as received by our customer, and responding to warranty/field issues and driving the appropriate corrective actions within the organization.
Supports and interfaces with R&D Engineering, Manufacturing, Operations, Purchasing, Planning, and Quality functions with document control activities. Consistently and accurately complete daily work assignments with a moderate degree of independence per standard work instructions is a fundamental requirement for success, along with initiating communication (verbal, email, etc.) and applying corrections as required to clarify, complete or resolve data and process compliance issues.
Reports to: Quality Assurance Manager
- Complies with company’s quality system requirements and any other applicable regulatory requirements.
- Develop and/or implement quality planning techniques in a manufacturing environment for existing products and new product introductions.
- Regulation/standard identification, packaging validations, expiry date determination, standard test methods and design of experiments.
- Maintains schedule, identifies and recommends solutions to specific aspects of a project.
- Active participation and support of the internal audit process. Investigates root cause and coordinates corrective action to audit findings.
- Recommends changes to existing internal system to improve the quality aspect of the product development process.
- Performs statistical evaluation of data pertaining to field returns, non-conforming product identified by production and supplier quality in order to identify areas for improvement.
- Participates in the development of FMEA and other risk assessment documentation.
- Participate in supplier qualification/development activities to ensure that products meet design and manufacturing requirements as part of the Supplier Quality program.
- Work closely with production line and ensure all necessary controls are effective and compliant with ISO requirements.
- Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement.
- Organize data, and generate reports for management review.
- Responsible for part number assignments, revision control of documents/drawings, processing engineering change orders and product data entry.
- Creating new, maintaining and updating existing drawings and work instructions.
- 1 – 2 years industry experience as a quality engineer or technician in both high-tech and manufacturing environments.
- Familiar with ERP system(create material, BoM and ECO, and run reports.
- Ability to perform edit-level tasks using AutoCAD, Pro/Engineer or SolidWorks
- Basic understanding of ISO 9000 requirements
- Working knowledge of GD&T and how it is applied.
- Possess statistical problem solving skills.
- Basic knowledge of electronic and/or mechanical components
- Experience interpreting product specifications, customer purchase orders; ability to read mechanical drawings.
- Good communication skills, both written and oral. Strong organizational skills with attention to detail and ability to multi-task.
- Must have the ability to create and edit Microsoft Word, Excel, PowerPoint files.
- Bachelor of Science degree in a technical engineering or industrial technology discipline is required; MS preferred.
- 1 - 2 years of experience as a Document Control Specialist or ECO Analyst or Engineering Services/Product Data administrator is preferred.
- ASQ CQE Certification or other training related to process improvement (e.g., Six-Sigma, Lean manufacturing, etc.)
- Experience working in ISO 13485 environment is a plus.
- Experience with calibration tools and techniques
- Working experience within Expandable.
- Experience as supplier quality engineer is a plus.
LumaSense is an Equal Employment Opportunity Employer and is committed to creating an environment which welcomes diverse people, opinions and ideas.