Junior Quality Assurance Engineer
Global Interconnect Inc
Job description
Background:
Global Interconnect Inc., an established company with a highly entrepreneurial culture located on Cape Cod, is looking to find a standoutJunior Quality Assurance Engineer to join our dynamic and growing team. If you are looking for a change and want an opportunity where you can truly make an impact and take your career to a rewarding level, we want to talk with you!
Why is Global Interconnect, Inc. (GII) interested in hiring a Junior Quality Assurance 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.
About GII
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 OEMs. These end devices and instruments are used around the world impacting, improving and in many cases saving lives each and every day.
https://www.globalinterconnect.com/
Job Summary:
The Junior Quality Assurance Engineer will have an important impact on the future success of the Company by driving the quality objectives of the Organization. The Junior 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 Junior Quality Assurance Engineer will work in concert with GII’s Asia and Costa Rica Quality Team and support activities related to First Articles, Finished Goods and Raw Materials to ensure compliance with customer and GII requirements and specifications. This role is built to grow: you will take ownership of core quality programs from day one and, with mentorship, expand into leading investigations and audits across the organization. Responsibilities include:
· Investigate and document customer complaints for key assigned accounts, with mentorship from senior quality staff, with cross functional teams, suppliers, manufacturing, engineering, account managers and customers
· Coordinate and document supplier corrective action investigations with cross functional teams, suppliers, manufacturing, engineering, program managers and customers
· Drive engineering change orders to closure for assigned customers
· Assist in audit program (internal, customer, ISO, FDA) and participate in corrective actions stemming from audits
· Act as critical approval coordinator in QMS software
· Drive customer requests for compliance certifications (REACH, RoHS, Conflict Mineral)
· Ability to assist other Team members in non-quality work activities as necessary
· Drive document control program at Global Interconnect controlling all Document Change Requests, in QMS software
· Track training plan and file associated training
· Administer facility quality programs, including equipment calibration and pest control monitoring, ensuring ongoing compliance with ISO 13485 requirements
· Drive supplier qualification requests, collecting pertinent information and filing into QMS system.
· Drive customer requested surveys, questionnaires and requests for key assigned customer accounts.
· Other key continuous improvement projects and activities as required.
· Own the bioburden schedule, tracking, trending and reporting on quarterly basis, as needed.
· Review sterilization reports and document certificates of compliance for customers, as needed.
· Provide quality consulting/direction on some assigned engineering projects.
· Participate in internal and supplier audits, with a path to Lead Auditor certification.
· Quality projects, as needed. (i.e. QMS software implementation, coaching/training sessions for non-quality team members in quality issues/theories, process improvements, assist teams in writing procedures/forms)
Requirements & Skills:
· 1-3 years of quality engineering/quality assurance experience (medical device or other regulated industry experience a plus)
· Ability to apply logical, scientific or analytical thinking to a wide range of intellectual and practical problems
· Lead Auditor Training certificate, a bonus
· Work independently as well as with a team
· Able to establish and maintain good customer relationships
· Embrace process and easily adjust to change
· Outstanding communication skills (verbal & written)
· Able to meet deadlines and work well under pressure in a fast-paced office environment
· Self-motivated with excellent time management and organizational skills
· Proficient with platforms such as Outlook, Excel, QMS software (i.e. QCBD) and MRP systems
· Available to meet with customers via video call and in person (some travel required)
· Knowledge of sterilization and sterile barrier packaging
· Knowledge of REACH, RoHS, conflict minerals
· Ability to proficiently read specifications, drawings and schematics
· General knowledge of cable assemblies, connectors, electrical testing, material biocompatibility.
· Experience working within a 21 CFR 820 (QMSR) and ISO 13485 environment
· Experience in generating PFMEA’s and Control Plans
· Bachelor’s degree in a technical field desired
Position is based in Pocasset, MA. Workdays, M-F. In office M-Th, WFH Friday.
If interested in exploring this exciting opportunity, we are eager to speak with you!
Pay: $65,000.00 - $80,000.00 per year
Benefits:
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401(k)
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401(k) matching
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Flexible schedule
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Health insurance
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Health savings account
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Life insurance
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Retirement plan
Work Location: In person