Job Description :
Pay Range $54.18hr - $59.18hr
Responsibilities :
- Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
- Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
- Participate in design and drawing reviews to ensure that components meet requirements for design and patient safety requirements.
- Develop, validate, and improve component inspection strategies and methods to ensure parts meet drawing requirements.
- Responsible for defining supplier qualification requirements for components and custom materials, including supplier validations, client's receiving inspection test methods, and fixture design.
- Develop, update, and maintain technical content of part qualification plans and reports.
- Investigate complex manufacturing product quality and compliance issues (e.g., Client, CAPA, SCAR) for all production processes prior to final product release based on engineering principles;
analyze results, make recommendations, implement corrective actions, and document reports.
Perform other duties and responsibilities as assigned.
Skills :
- Effective communication and conflict resolution skills, team player.
- Highly organized and detail-oriented.
- Effective problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc).
- Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to Client’s and SCAR’s.
- Ability to make sketches, engineering drawings, and common computations.
- Ability to read and interpret technical drawing, schematics, and computer-generated reports.
- Previous experience with computer applications and software related to the engineering field, such as Computer Aided Design (CAD).
- Understanding of Risk Management principles.
- Previous experience with Keyence routine programming.
- Six Sigma Green or Black Belt / LEAN Manufacturing experience is a plus.
- Ability to manage competing priorities in a fast-paced environment.
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
Education and Experience :
- Bachelor's degree (Engineering or Science) is required with 4 years of experience required or Master’s Degree (Engineering or Science) and 3 years of related experience required.
Senior Supplier Qualification Engineer
Responsible for defining supplier qualification requirements for components and custom materials, including supplier validations, client's receiving inspection test methods, and fixture design. Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering ...
Senior Supplier Quality Engineer, NPD
Edwards Lifesciences has an opportunity for a Senior Engineer, Supplier Quality on the Transcatheter Mitral and Tricuspid Therapies (TMTT) team. The Senior Engineer will apply knowledge of quality engineering principals and methods to ensure compliance with regulatory requirements and Edwards’ syste...
Senior Supplier Quality Engineer, Manager
Systematically, drive the supplier quality development processes throughout the product development stages with the product engineering team through design reviews, supplier process development, testing, and qualification for components and sub-assemblies for precision mechanical parts. Partner with...
Senior Supplier Quality Engineer - Wire Harness & Cables
Drive the supplier quality development processes throughout the product development stages with the product engineering team through design reviews, supplier process development, testing, and qualification for components and sub-assy for cables and wire harness products. Drive supplier quality readi...
Sr. Quality Assurance Engineer
Leads the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices. Integrates ISO 14971, risk management and IEC 623...
Senior Quality Engineer
Senior Quality Assurance Engineer - Lithium-Ion Battery Production - San Diego County. I'm looking for an experienced Senior QA/QC Engineer to manage & maintain my client's quality system and standards as they manufacture their state-of-the-art batteries. Senior Quality Assurance Engineer - Lithium-...
Product Quality Engineer
We are looking for a skilled Quality Engineer to support manufacturing, biocompatibility, sterilization, and packaging validation for structural heart implants, delivery systems, and robotic devices. Monitor product quality during production, ensuring GMP compliance and adherence to internal quality...
Quality Assurance Engineer
We are seeking some experienced QA Engineers to join us! In our team, you can always stay at the forefront of technology, have access to and learn about the latest generation of networking technologies worldwide. Together with other outstanding engineers in the team, you will create reliable, stable...
Air Quality Engineer I, Department Of Consumer Affairs
Under the general supervision of the Senior Air Quality Engineer (Senior AQE) and project leadership of an Air Quality Engineer II (AQE II) where assigned, the Air Quality Engineer I (AQE I) performs staff level engineering work within the Certification and Schools Support Unit. Laboratory and Field...
Quality Engineer I
Assesses quality performance (or cost-of-quality) using statistical and analytical methods. Develops and establishes quality systems and procedures, inspection plans, quality performance trends,. Practical knowledge of state-of-the-art inspection and quality engineering/assurance techniques,. Develo...