Summary

The Quality Assurance Engineer will have an important impact on the future success of the Company by driving the quality objectives of the Organization. The Quality Assurance Engineer applies technical quality assurance methods to ensure standards are met during all phases of the product lifecycle. The individual 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 Assurance Engineer will work in concert with GII's Asia Quality Team and support activities related to First Articles, Finished Goods and Raw Materials to ensure compliance with customer and GII requirements and specifications.

Job description

Job Summary

The Quality Assurance Engineer will have an important impact on the future success of the Company by driving the quality objectives of the Organization. The Quality Assurance Engineer applies technical quality assurance methods to ensure standards are met during all phases of the product lifecycle. The individual 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 Assurance Engineer will work in concert with GII's Asia Quality Team and support activities related to First Articles, Finished Goods and Raw Materials to ensure compliance with customer and GII requirements and specifications.

Responsibilities

Represent Quality and lead Quality initiatives throughout cross functional lifecycle of customer experience from new customer, engineering and development, first article and sustaining production with the ability to work independently juggling multiple priorities with shifting timelines
Review and approval of protocols and quality related reports including Qualification Test Plans (QTP) and First Article Reports
Provide input and guidance to manufacturing line set-up, equipment validation and quality system related processes
Lead and document customer complaint investigations with cross functional teams, suppliers, manufacturing, engineering, program managers and customers
Responsible for supplier qualifications to support procurement and to drive actions (questionnaires, audits, and quality agreements)
Lead and document supplier corrective action investigations with cross functional teams, suppliers, manufacturing, engineering, program managers and customers
Ability to disposition source inspections in an efficient and timely manner to meet internal and customer deadlines
Schedule and drive process audit program to ensure suppliers are maintaining outstanding quality
Support team members from a quality perspective by providing input to qualification, validation and test protocols/reports
Drive engineering change orders to closure
Lead audit program (internal, customer, ISO, FDA) and drive corrective actions stemming from audits
Lead internal training program for QMS and yearly training program
Ability to drive quality system improvements with key manufacturing partners
Ability to assist other Team members in non-quality work activities as necessary
Drive calibration and pest control program(s)

Requirements

Apply technical quality assurance methods across the product lifecycle
Work independently while juggling multiple priorities with shifting timelines
Interact directly with customers and suppliers to drive systematic corrective actions
Review and approve protocols and quality reports including Qualification Test Plans and First Article Reports
Lead customer complaint investigations with cross-functional teams
Perform supplier qualifications including questionnaires, audits, and quality agreements
Lead supplier corrective action investigations
Disposition source inspections to meet internal and customer deadlines
Drive process audit programs
Support qualification, validation, and test protocols/reports
Drive engineering change orders to closure
Lead internal, customer, ISO, and FDA audit programs and corrective actions
Lead internal QMS and yearly training programs
Drive calibration and pest control programs
Collaborate with cross-functional teams, suppliers, manufacturing, engineering, and program managers

Company overview

Global Interconnect, Inc. (Gii) is an ISO 13485-certified and FDA-registered contract manufacturing partner specializing in energy-based and diagnostic medical devices, including scopes, probes, catheters, and finished sub-assemblies. Founded in 1995 and headquartered in Pocasset, Massachusetts, Gii has served medical device OEMs for over four decades, combining value-added engineering expertise with advanced manufacturing capabilities. The company's core competencies span electromechanical assemblies such as PCBAs, custom connectors, cables, and electronic configurations, alongside precision molding, extrusion, machining, coating, stamping, cleanroom assembly, sterilization, and packaging. Through its Value Engineering approach, Gii helps OEMs consolidate supply chains, reduce costs, accelerate time-to-market, and ensure regulatory compliance. With operations in the United States, Hong Kong, China, and Central America, and access to over 10,000 workers and 1.5 million square feet of manufacturing capacity, Gii supports the world's largest medical device manufacturers in building tens of millions of devices annually. The privately held company is led by founder and CEO Stephen Bates.