Foxconn Industrial Internet (Fii) provides innovative design and advanced manufacturing capabilities through Artificial Intelligence driven solutions. Dedicated to the expansion of AI-driven platforms, Fii centers around Cloud Based Computing, Big Data, High-Speed Networks, Automation, and Industry 4.0 methodology. Join an expansive network of professionals who embody an entrepreneurial spirit that works together within a company culture of shared mission.
As a Supplier Quality Engineer, you’ll have responsibility for and authority to provide Quality Assurance Engineering representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness.
- Coordinate feedback of quality indicators and statistics to business team for use in business decisions.
- Partner with Manufacturing Engineers in process improvements. Perform, direct, or consult in validations.
- QA approvals for Engineering Change Notices, test methods, and test equipment to assure the design and production of medical devices follow applicable standards.
- Drive investigations, corrective action implementation, and corrective action verification activities assigned to business teams.
- Partners with R&D, Business Development, NPD Quality, Manufacturing Engineering to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data for significance, and other documented requirements for quality objectives.
- Participates in all new product development phase gates including select suppliers, qualify new suppliers, and setup supplier controls.
- Investigates and reports on supplier corrective actions effectiveness and timeliness.
- Participate on Corporate Supplier Quality Teams.
- Develop and ensure proper execution of the Supplier Quality Strategy.
- Partner with Supply Chain to integrate strategies and ensure coordination and alignment across Sector.
- Assist with supplier development by evaluating and developing supplier processes through process and product and/or tooling validations and provide assistance, conduct supplier review meetings and supplier training.
- Develops and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.
- Leads Supplier Qualification activities: Supplier Audits & Supplier Quality Agreements.
- Other Duties as Assigned.
- Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or
- Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality
- Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
- Strong Knowledge of 13485 Standards
- May have broad knowledge of project management
- Experience in application statistical methods to design reliability and process capability
- ASQ certification in Quality Engineering
- Experience and working knowledge of FDA regulations/ISO standards for medical devices
- Strong interpersonal, organizational and project management skills
- Demonstrated skills in decision making
- Demonstrated ability in coaching/developing team members
- Demonstrated communication skills, both verbal and written
- Strong interpersonal communication and influencing skills
- Ability to work in a team-based environment
- Very strong in quality and compliance
- Computer skills in MS Office and ERP systems desirable
Job Type: Full-time
- 401(k) matching
- Dental insurance
- Disability insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
- Quality Engineer: 5 years (Preferred)