Quality Assurance Specialist

The position of Quality Assurance Associate III is within our CMI business unit.
Under the supervision of the Supervisor/Manager, the scope of this position is
responsible for carrying out the daily operations in the batch record department.
This job description will be reviewed periodically and is subject to change by
management.
RESPONSIBILITIES:
• Demonstrated ability to carry out assignments in a timely, accurate manner
and accomplishing tasks as required with little or no supervision.
• Ability to interact effectively with all levels of the organization and perform
multiple tasks in a fast-paced environment.
• Proficient in one or more Quality processes such as incoming inspection,
and/or change management, and/or records (including batch release). May
JOB DESCRIPTION
Quality Assurance Associate III June 2023
also support some record administration and batch record review duties,
including Certificate of Analysis / Certificate of Conformance creation and/or
review for material lot release.
• Work with groups within the organization to get corrections and
clarifications to Device History Records.
• Facilitates the Change Control process in the electronic change control
system and tracks the change process through development, approval, and
implementation.
• Able to assist others with Change Control process and offer guidance and
best practices.
• May prepare labeling for all finished product and perform labeling of
product.
• Analyzes and interprets the significance of the proposed changes using
independent judgment to guide change initiators in the development of
accurate change requests.
• Reviews standard operating procedures, logs, forms, manufacturing records,
work instructions and all other Quality records for adherence to established
templates, good documentation practices and adequacy of referenced
procedures and part numbers.
• Utilize database to perform transactions and verify product information.
• Generate and/or review Certificate of Conformance / Certificates of Analysis
for Final Product.
• Filing of records.
• Communicates issues effectively and partners with cross-functional
associates to meet compliance requirements.
• Is able to leverage collaboration and helps to drive organizational
improvements with compliance issues.
• Able to troubleshoot issues and improve systems as needed.
• Is able to coach staff, in real-time, to resolve issues and improve future
outcomes.
• Works on assignments that are complex in nature where considerable
judgment and initiative are required in resolving problems and making
recommendations.
• Knowledgeable of federal and other regulations, e.g. QSRs, ISO 13485,
CMDR, etc.
• Understands and is aware of the quality consequences which may occur
from the improper performance of their specific job; has awareness of
device defects that may occur in their area of responsibility, including
product design, verification and validation, manufacturing and testing
activities.
• Responsible for exhibiting professional behavior with both internal/external
business associates that reflects positively on the company and is consistent
with the company's policies and practices; build productive internal/external
working relationships.
• Carries out duties in compliance with established business policies.
• Other duties as assigned, according to the changing needs of the business.
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
• High School Diploma or GED.
Quality Assurance Associate III June 2023
• 3-5 years of related experience.
• Experience with MS Office.
• Able to work on multiple tasks as a team member and/or ability to operate as
an individual contributor.
• Must be detail-orientated, self-motivated and available for flexible
scheduling
• Strong communication, problem solving and motivational skills.
PREFERRED QUALIFICATIONS:
• Bachelor's Degree.
• Working knowledge of Quality Assurance in a medical device manufacturing
environment, preferably in-vitro diagnostic.
• Knowledge of Quality System Regulations.
COMPETENCIES:
• High level of attention to detail
• Teamwork
• Communication
• Strong organizational skills
• Initiative
• Adaptability