QA Technician

The Quality Assurance Technician performs receiving inspection of electronic medical devices and reprocessing efforts of devices to ensure product conformance meets technical specifications and requirements. This position reports to the Quality Manager. Full-time (9 am - 5 pm, M-F), on-site, salary position. Salary DOQ. No walk-ins please.

Core Responsibilities include:

· Perform the following tasks with a sense of urgency: receiving inspection, performance validation of new products, customer returns and RMA inspection and reprocessing of returned devices.

· Ensure that products and related documentation meet internal specification and customer requirements. Including but not limited to identifying areas for improvement, creating processes, writing processes and procedures.

· Ensure that each job performed is documented per inspection procedure and completed to the highest accuracy level. Creating inspection procedures and reviewing processes.

· Perform or evaluate First Article Inspections and complete documentation as required.

· Witness/perform tests and verify compliance to test specifications and evaluate test data results.

· Various forms of data entry as part of product inspection and acceptance, recording results on inspection logs, creating processes within our portal and retaining records.

· Manage Nonconforming devices and collaborate with other departments to disposition nonconformances accurately and on a timely basis. Assist with FDA compliance, audit readiness and review/retain records according to regulations.

· Perform other duties as assigned.

Do you have experience in Technical Proficiency?, Do you have a High school diploma or GED?, · Candidates shall have electronic product experience to identify and resolve issues accepting product configuration and performance.

· Ability to effectively operate and interpret basic electronic measuring devices.

· A Secondary Certificate/ High school diploma and willingness to learn on-the-job, associate or bachelor’s degree preferred but no required.

· A minimum of 3 years or more of relevant experience in QA, medical devices or pharmaceutical company required.

· Knowledge of regulatory compliance requirements, FDA and ISO is required.

· Ability to define lot acceptance sampling plans in accordance with lot size vs. sampling size standards and calculations.

· Ability to handle multiple tasks and meet deadline requirements with minimal supervision.

· Strong work ethic and sense of urgency, self-motivated and possess a desire to achieve goals.

· Ability to interact effectively at all levels internally and externally.

· Strong computer proficiency, particularly with MS Word, Outlook and Excel.

Physical Demands

· Employee is required to sit or stand for extended periods of time, reach with hand and arm, and lift up to 50 pounds.

Professional Attributes

· Be ambitious and accountable.

· Engage and work with teams and manage workload.

· Teamwork - Connected to the business, communicates openly, shares information and knowledge, networks internally and externally, involves colleagues, respects colleagues.

· Responsive - Always reacts quickly and with a sense of urgency to requests, issues, e-mails or other events in a timely and flexible fashion.

Pulled from the full job description

• 401(k)
• Health insurance
• Paid time off
• Vision insurance
• Dental insurance
• Life insurance, * 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance