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:
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
