Role and Responsibilities
Key team member supporting inspections of all raw materials, materials in process, and finished products, supplier quality engineering. Demonstrates expertise in a variety of Quality Assurance Engineering concepts, practices, and procedures. Ensures projects are completed on time and within budget. Acts as advisor to quality assurance engineering team regarding projects, tasks, and operations. Provides consultation on complex projects and is considered to be a critical contributor/specialist. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of complex tasks. A certain degree of creativity and latitude is required. Typically reports to a unit/department head.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Performs Supplier Selection, Audits, Reviews and Corrective Actions.
- Interact with suppliers to ensure compliance.
- Design, implement and document procedures from process control, process improvement, testing and inspection.
- Creates quality standards and protocols for quality assurance testing models.
- Assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment.
- Support Quality Engineering team by providing data for system improvement activities and advises on root cause analysis.
- Analysis, corrective action and feedback of product returned by customer service from field failures.
- Selection and development of improvement projects utilizing the DMAIC methodology & interface with Engineering Team to decide on required product improvements.
- Support in-process and final audits.
- Knowledgeable of APQP & the development of Flowcharts, PFMEA's and Control Plans.
- Failure analysis, preventive and corrective action for defective components and subsystems.
- Participate in kaizen events for continuous improvement activities
- Assist in the development of inspection jigs, poka yoke devices and testing fixtures along with required process documentation.
- Maintains quality assurance records.
- Utilizes corrective action process to ensure that issues are documented and monitored to closure.
- Undertakes decisions and recommendations within established guidelines and procedures.
- Exercise judgment and time management skills in completing recurring assignments independently.
- Works under direction with considerable scope for independent judgment.
- Other duties as assigned.
- BS degree in Technical Field such as: Mechanical, Electrical, and Electro-Mechanical Engineering.
- 10+ years’ experience in Quality Assurance Engineering disciplines & Technical Experience.
- ISO 9001 experience is required.
- Experience with Microsoft Office products.
- Excellent written and verbal communication skills.
- Excellent problem-solving ability.
- Change agent- driving Quality culture in organizations.
- Good written and verbal communication skills.
- Ability to work well in a team environment.
- Ability to interface with customers at all levels
- Innovation/creativity, managing/working with others, project/process management, accountability
- FMEA Certified preferred.
- ISO 13485 Certified (medical) preferred.
- ability to lift up to 50 pounds
- ability to sit and stand for extended periods of time