Quality Assurance Specialist

Quality Assurance Specialist Nurse Assist, Inc. - 3.8 Haltom City, TX Job Details Permanent | Full-time 17 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Vision insurance Life insurance Qualifications Statistics Communication with suppliers Quality control statistical data analysis Statistical Process Control Manufacturing facility Statistical analysis Bachelor's degree Vendor communication Biomedical regulatory compliance Productivity software Quality audits Regulatory compliance analysis Process management Customer service problem-solving

ISO 13485 FDA

regulations Full Job Description

JOB TITLE

Quality Assurance Engineer Specialist

DEPARTMENT

Quality

POSITION REPORTS TO

Quality Manager

SALARIED

[ X ]

HOURLY:

[ ]

BASIC PURPOSE OF POSITION

Technical Quality Assurance resources for Nurse Assist Quality Management Systems, Operations and QA/QC areas. Provides quality assurance compliance support to all areas of product development and production. Provides guidance on solutions to moderately complex problems. Analyzes existing operations against the regulatory requirements of

ISO 13485, ISO

14971 and 21

CFR:

820, audit support for MDSAP and proposes enhancements in compliance for those operations, to those regulations.

ESSENTIAL FUNCTIONS/DUTIES

Will provide technical consultation on new product development, drawing on a degree of design and validation experience. Manages portions of the Quality System such as complaints/CAPA/NCR. Statistical Process Controls, trending and analysis presentation. Executes portions of the Quality Systems such as RGA/QA Office/Quarantine/Labeling/Incoming or In-process Inspections. Completes investigations and corrective actions for specific incidents in the complaint/CAPA/NCR systems. Writes and/or approves documents in support of change control/document control. Write/update procedures for new or updated processes as needed. Will implement processes to assure the quality of products manufactured at this facility. This is accomplished by working with a multidisciplinary team of professionals. Audit support as SME for Internal and External audits. Audit production and/or quality operations against ISO 13485, MDSAP and 21

CFR:

820 requirements. Will assist with employee training (across all departments). Works closely with manufacturing engineering to improve processes. May interact with suppliers and customers May perform quality testing according to company documented test procedures, GLP, and USP (Good Laboratory Practices and United States Pharmacopeia) when needed. Understand good safety practices in handling hazardous chemicals in the laboratories.

KEY WORKING RELATIONSHIPS

INTERNAL:

Must be able to work as part of an interdisciplinary team interacting easily with the members of the team. Must be able to support the ongoing manufacturing of products. Must be able to provide technical consultation to other personnel in a positive, supportive way.

EXTERNAL

Must be able to work with outside vendors in support of product production and testing. Must be able to interact with customers in solving customer problems. Must be able to work with external auditors.

SUPERVISORY RESPONSIBILITIES

None

EDUCATION AND EXPERIENCE REQUIREMENTS

Bachelor's degree or equivalent. Quality Industry training courses. At least 5 years of quality assurance experience in the appropriate field. Experience in the medical products field and/or disposable product manufacturing is preferred. At least 3 years of experience with

ISO 13485

regulations and FDA GMP and QSR requirements. At least 3 years of Statistical Process Control (SPC) implementation experience in a high-volume environment. Must be proficient in the use of office automation software including MS Word, Excel, PowerPoint.

Job Types:

Full-time, Permanent Benefits:

401(k) Dental insurance Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person