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- Ithaca, NY 14851
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Quality Assurance Associate
Transonic • Ithaca, NY
Posted 1 month ago
This is a role with dual responsibility; those assisting in the management & maintenance of the document control systems, and those focusing on New Product Development & post-market surveillance. Additional duties and projects to be assigned based on business needs and strengths and interests of the candidate.
Duties and Responsibilities
Assists in design and implementation of quality system documents; assess documentation problems and recommend solutions.
Establish filing systems and databases, port information into them as directed.
Manage and reconcile issues with the document control system including Innovator and Work Instruction System.
Manage and track the flow of both electronic and hard-copied controlled documents, QA department files and quality records.
Format, process and release Engineering Change Orders (ECO) and Deviations in Innovator as the Primary Change Specialist.
Transfer released ECO and Deviation information into TRACS.
Issue calibration due notifications and maintain calibrations records in Innovator.
Process Safety Data Sheets (SDS) in Innovator.
Perform two-year reviews on document control work instructions, forms, and standard operating procedures.
Initiate change orders to create or update Quality System Procedures.
Make and document reportability decisions for incoming customer complaints
Help support and assist in continuous improvement projects for Quality Systems and support continuous improvement efforts from other departments as needed. NOTE: Typical continuous improvement projects include supplier quality, process/procedure/workflow improvement, and product compliance planning.
Will be required to support Quality Engineers and perform other work-related duties as requested, directed or assigned by management.
Internal departments such as: Quality Assurance, Regulatory, Engineering, R&D, Planning, Manufacturing and General Administration
External vendors as necessary
Education and Experience
A minimum of a BS in Engineering or an AS (technology or management) plus 3 years professional experience is required
Prior experience in a medical device or other highly regulated environment is preferred
Member of America Society for Quality (ASQ) preferred
Knowledge, Skills and Abilities
Good organizational skills. Detail oriented.
Good written, oral, interpersonal, group and telephone communication skills
Ability to use Microsoft Office Suite including Microsoft Word, Excel, PowerPoint and Outlook
Knowledge of the following topics preferred:
Statistical Process Control
Design validation and verification
Process validation (IQ, OQ, PQ)
Standards compliance such as electrical safety, EMC, biocompatibility, usability
No Direct Reports
Position primarily requires sitting, standing, talking and walking in an office environment and stooping, climbing, standing, walking and talking in a processing environment.
Nature of work requires depth perception, close and far vision, normal color distinction, potential for eyestrain and normal finger dexterity.
Ability to adhere to safety requirements
Primarily Office environment with occasional work in manufacturing and processing environment.
The position may require periodic use of personal protective equipment.
Disclaimer: This Job Description is not intended to be all-inclusive and may be subject to change to include new responsibilities and tasks or change existing ones as management deems necessary to meet the ongoing needs of the company.