The time has come to make your next career move. You’re looking to join a respected and well- established organization that’s going to further elevate your professional career and help you achieve your goals. Best of all, with an organization that is presented with vast new business opportunity and tremendous upside potential. We’re only on this Earth once so why work for an employer that doesn’t value your contributions or is limiting your full potential. If you want to make an impact and push your talents to another level while helping an organization achieve its ambitious growth plans – we want to talk to you!
Why is Global Interconnect, Inc. (GII) interested in hiring a Quality Engineer?
GII has ambitious growth goals and is committed to doubling the size of the organization in the next 5 years. The opportunity is extremely ripe for the right candidate to be a key contributor to this growth. With our strong product development and engineering process, Global Interconnect needs to add another Quality Engineer to its growing Team and add to the resources responsible for driving our robust quality management system.
Global Interconnect, Inc. is a design, engineering, and manufacturing firm with headquarters in the US and offices in Hong Kong and China. Our niche and primary focus is providing custom cable, wire and harness assemblies of unparalleled quality for medical device and high-end industrial OEM’s. These end devices and instruments are used around the world impacting, improving and in many cases saving lives each and every day.
As a member of the Quality Team, the Quality Engineer is responsible for successfully driving the quality objectives of Global Interconnect, Inc (GII). The Quality Engineer applies technical quality assurance methods to ensure quality standards are met during all phases of the product lifecycle. He or She will interact directly with GII’s customer and supplier base to understand, address, work through, and drive systematic corrective actions to reconcile quality issues impacting the Organization. The Quality Engineer will work in concert with GII’s Asia Quality Team and support QA activities related to First Articles, Finished Goods and Raw Materials to ensure compliance with customer and GII requirements and specifications.
- Duties and Responsibilities
The following represents a list of essential duties and responsibilities. Other duties may be assigned as required.
- Successfully work with project teams both within Global Interconnect Inc. and outside the organization to drive project milestones and company objectives, as they relate to quality.
- Drive the lifecycle of Corrective Action Requests (CAR’s), Non-Conformance Reports (NCR’s), Supplier Corrective Action Reports (SCAR’s) and Customer Complaints from initiation to completion.
- Ability to assist with customer audits, ISO audits and FDA inspections.
- Perform detailed inspections and targeted testing of incoming raw materials, labels (proofing and UDI verification) finished goods to ensure compliance with Company and Customer specifications.
- Lead First Article (FA) and First Production (FP) documentation activities which include, but not limited to, defining FA & FP documentation requirements, communicating FA & FP documentation requirements to GII’s Suppliers and China based Team, participation in New Product Introductions (NPI) to ensure all necessary test data is requested, review of data and measurements for accuracy and completeness, final compilation and management of completed packages.
- Assist in laboratory upkeep and managing measurement equipment calibration.
Day-to-day decision making for all areas of responsibility to include, but not limited to, customer inquiries, Technical Documentation, First Articles, New Product launches and procedure revisions.
- Collaborate with Quality Assurance and Engineering Team members to assist in root cause/failure analysis activities.
Help drive Process Improvements through collaboration with our GCN Team and manufacturing partners.
Assist in maintaining, updating, revising, and storing documentation per Company protocols.
- Provide Supplier Performance monitoring support as it relates to metrics gathering, tracking and reporting.
- Provide support in the development of corrective action plans for material non-conformances utilizing established quality engineering techniques.
- Assist in the lifecycle of Corrective Action Requests (CAR’s), Non-Conformance Reports (NCR’s), Supplier Corrective Action Reports (SCAR’s) and Customer Complaints from initiation to completion.
- Review and analysis of Inspection Reports generated from GII’s Suppliers and China based Team to propose final accept/reject decisions.
- Assist in establishing, implementing and maintaining the ISO (9001 and 13485) quality management system and FDA 21 CFR Part 820 as they pertain to procedures striving for continuous improvements.
Other assigned tasks as required.
The Quality Engineer carries out assigned responsibilities under the direction of the Director of Quality in accordance with Company policies.
Qualification and Desired Skills
To perform this job successfully, an individual must be willing and able to perform each essential responsibility satisfactorily.
- BS in Engineering / technical discipline
- Knowledge of medical device GMP and ISO 13485 requirements.
- Knowledge of FDA 21 CFR Part 820.
- General knowledge of Mechanical and Electrical Engineering
- Ability to interrupt general drawings/specifications for product.
- Electromechanical aptitude
- Willingness to learn
- Ability to take basic electrical and mechanical measurements
- Ability to compile and write technical reports and data packages
- Ability to communicate technical issues to customers and suppliers in a timely manner
- Strong analytical skills along with excellent written/verbal/ interpersonal communications skills, with high energy and a professional drive to win
- Proficiency or experience in 2D drafting and 3D modelling in programs such as AutoCad & Solidworks
If interested in exploring this exciting opportunity, we are eager to speak with you!
Please direct cover letter and copy of your resume to email@example.com