Quality Systems Manager Nurse Assist, Inc.

• 3.

6 Haltom City, TX Job Details Full-time 20 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Vision insurance Life insurance Qualifications Microsoft Word Customer communication Microsoft Excel Team leadership English Regulatory/legal compliance standards in production Biomedical regulatory compliance Quality audits General management

ISO 13485 FDA

regulations Full Job Description

JOB TITLE

Quality Systems Manager

DEPARTMENT

Quality

POSITION REPORTS TO

Vice President of Quality

SALARIED

[ X ]

HOURLY:

[ ]

BASIC PURPOSE OF POSITION

Manages the site Quality Management System and Quality Systems team to ensure compliance with

ISO 13485, 21 CFR

Part 820, company procedures, and customer requirements. Provides oversight of quality records, data trending, management review, and site quality improvement activities.

ESSENTIAL FUNCTIONS/DUTIES

• Manage the site Quality Management System in compliance with

ISO 13485, 21 CFR

Part 820, company procedures, and customer requirements.

• Oversee nonconformances (NCs), corrective and preventive actions (CAPAs), Change Control, Complaints, and Document Control.
• Ensure Quality System records and investigations are complete, risk-based, supported by objective evidence, and completed within established timelines.
• Trend site quality data, identify recurring issues and systemic risks, and escalate significant quality concerns.
• Preparation and communication of quality metrics and management review materials and track resulting actions through completion.
• Support the development, implementation, monitoring, and completion of the Site Quality Improvement Plan.
• Develop, revise, approve, and maintain Quality System procedures and controlled documents.
• Manage the organization's labeling and UDI compliance program, ensuring product identification, traceability, labeling control, and regulatory compliance with

ISO 15223, ISO 13458, 21 CFR

Part 820, and applicable FDA UDI requirements.

• Manage site Risk Management files and associated documentation throughout the product lifecycle, ensuring timely reviews, updates, and compliance with

ISO 13485, ISO 14971, 21 CFR

Part 820, and internal quality system requirements.

• Support regulatory inspections, internal audits, customer audits, and certification-body audits.

KEY WORKING RELATIONSHIPS

INTERNAL:

Works cross-functionally with Operations, QA/QC, Validation, Regulatory Affairs, and site leadership to maintain Quality System compliance and effectiveness.

EXTERNAL

Interacts with customers, suppliers, auditors, certification bodies, and regulatory authorities regarding Quality System activities and issue resolution.

MANAGEMENT AUTHORITY

• Manage, coach, train, and assign responsibilities to Quality Systems personnel.
• Establish team priorities, objectives, workload, and resource needs.
• Approve or reject Quality System records within assigned authority.
• Require additional investigation, containment, correction, or objective evidence when needed.
• Escalate significant, overdue, recurring, or ineffective quality issues to senior management.
• Recommend suspension of activities when product quality or regulatory compliance requirements are not met.

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• Minimum of five years of Quality Systems experience in a regulated manufacturing environment, including management or team leadership experience.
• Working knowledge of

ISO 13485, ISO 14971, ISO 15223, ISO

11137, and 21 CFR Part 820 requirements.

• Proficiency in Microsoft Word, Excel, and other applicable quality-system software.

PREFERRED QUALIFICATIONS

• Quality Systems experience in the medical device or pharmaceutical industry.
• Experience managing NC, CAPA, complaint, document control, change control, audit, and management review processes.
• Certified Quality Manager, Quality Auditor, or equivalent professional certification.
• Multilingual capabilities, including English and Spanish, are a plus.

JOB REQUIREMENT FACTOR RATINGS

H

• High importance M
• Medium importance L
• Low importance Hearing H Seeing H Reading H Speaking H Balancing M Walking M Use of hands H Use of arms H Use of legs M Lifting (max of 20 lbs.

)

M Bending M Standing L Sitting H Benefits:

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

Work Location:

In person