Quality Assurance - Qa Specialist

New employees are eligible for the following benefits effective date of hire!

• Medical, dental, and vision benefits
• Company-paid life insurance and disability benefits
• Generous Paid time off and 11 paid Holidays
• Tuition Reimbursement
• 401k Plan with Company Match

Company Overview

Meraqi Medical , now a part of Viant Medical, provides design, development, and manufacturing services to medical device companies in the bioelectronics, interventional and structural heart, and minimally invasive surgical spaces. Meraqi provides solutions from early brainstorming, conceptualizing and prototyping, to full design and development, as well as clinical and commercial manufacturing.

Viant Medical is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn .

Position Summary

The QA Specialist is responsible to provide general quality assurance support in the areas of inspection, document control and the overall maintenance of the Quality management system. This position supports both R&D and Operations through all pha ses of product lifecycle

Essential Duties And Responsibilities

• Reviews, approves and processes Engineering Change Orders.
• Conducts failure investigations related to customer complaints and implements corrective and preventive actions as necessary.
• Develops inspection requirements and sampling plans for components and performs inspection activities as needed. Uses measuring tools, such as gage pins, height gages, calipers, optical instrumentation, etc., to inspect materials, components and fixtures.
• Maintains supplier qualification and part receiving requirements (e.g. ASL, FAI, Supplier Evaluation, Supplier Auditing, etc.).
• Assists in the training of company employees in Quality System related procedures or processes.
• Prepare, distribute, and control documents in accordance with the document control procedures. Confers with document originators or other personnel to resolve discrepancies and compiles required changes to documents.
• Supports various manufacturing activities and actively participates in the development, qualification and validation of product/equipment and processes.
• Assists R&D in test method development.
• Performs Quality review of documents related to QC testing, receiving inspection and product release activities as required.
• Leads quality improvement projects that benefit the quality system, inspection, testing, assembly, or development of products.
• Coordinates the investigation and closure of Corrective Actions and NCMR's.
• Develops and implements effective inspection, measurement, and test equipment to verify compliance of product with specifications.
• DHR/LHR review and closure.
• Participates in the maintenance of an ISO 13485 and FDA QSR Compliant Quality Management System.
• Other duties as assigned.

Communication Skills

Good communication skills both oral and written.

SUPERVISORY RESPONSIBILITY

None

Required Education, Experience, Skills And Knowledge

• 0-2 years of recent experience in medical device industry, preferably with catheter based/disposables. Cardiovascular experience a plus.
• High School or equivalent combination of education and experience.
• Knowledgeable of a variety of testing equipment and their uses (including Instron, pin gages, snap gages, micrometer, caliper, etc.).
• Proficient use of documentation programs (e.g., Microsoft Office Windows, Excel, Power Point, etc.).

WORKING CONDITIONS / PHYSICAL DEMANDS

Must be able to move throughout office and laboratory space, using a complete variety of office equipment and laboratory machinery, and tools. May lift up to 20 pounds and stand for extended periods of time. Must tolerate exposure to chemicals and noise from machinery found in the Meraqi Medical Inc environment

PAY RANGE

We offer market competitive compensation. Potential hourly range for this role is $35-$50/hr. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Apply Now