Top 139 Quality assurance manager Jobs in Allen Tx

Sr. Manager - Quality Assurance
Atrion Corporation | Halkey Roberts Corporation, Quest Medical, Inc., Atrion Medical Products —Allen, TX
- Full-time
- 5 years
- Bachelor's degree
- Senior level
- 401(k) matching
Quick Apply
Home Loans Quality Assurance Team Manager- Vice President
Morgan Stanley —Dallas, TX
- $110,000 - $190,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Bachelor of Science
Manager, Quality Assurance
Quest Diagnostics —Lewisville, TX
- Full-time
- Sales
- Writing skills
- Mid-level
Quick Apply
Quality Assurance Manager
WILEY X INC —Frisco, TX
- $70,000 - $90,000 a year
- Full-time
- 3 years
- Senior level
- Associate's degree
Quick Apply
Project Manager – QA Automation
Sonoma Consulting Inc. —Plano, TX
- Contract
- Senior level
Quick Apply
Manager, Quality Assurance
Scotiabank —Dallas, TX
- $8,750 a month
- 5 years
- Finance
- SQL
- Referral program
4d
Quality Assurance Automation Manager
7-Eleven —Irving, TX
- Java
- Supervising experience
- Mentoring
Associate Procurement Quality Manager
Aligned Data Centers, LLC —Plano, TX
- Full-time
- Microsoft Access
- Microsoft Outlook
- Mid-level
- Health savings account
- Paid holidays
Quick Apply
Supervisor Quality Control - DMX
Southwest Airlines —Dallas, TX
- $145,600 - $161,800 a year
- Weekends as needed
- 18 years or older
- Computer literacy
- English
- Profit sharing
- Health insurance
5d
Senior Manager, Data Quality & Issue Management
Toyota —Plano, TX
- Office
- SQL
- Mentoring
- Health savings account
- Paid holidays
Regional Quality Manager
Resource Label Group —Plano, TX
- 5 years
- Travel
- Manufacturing
- Paid holidays
- Disability insurance
Quick Apply
12d
Quality Assurance Manager - Universal
AIT Worldwide Logistics, Inc. —Coppell, TX
- Online Application
- Customer service
- 5 years
- High school diploma or GED
- Paid parental leave
- Health savings account
Software QA Manager
Sol-Ark, LLC —Allen, TX
- Full-time
- Computer Science
- Software troubleshooting
- 5 years
- Health savings account
- Health insurance
Quick Apply
3d
Quality Manager
Prysmian Group —McKinney, TX
- 5 years
- Engineering
- Data analysis skills
9d
Manager, Regulatory Affairs and Compliance
Nordson —Allen, TX
- Online Application
- 5 years
- Bachelor of Science
- Bachelor's degree
Auto Ops Manager
Fanatics Collectibles —Allen, TX
- Call employer
- Microsoft Outlook
- Inventory management
- Mid-level
Quick Apply
Customer Quality Manager
OmniOn Power Inc. —Plano, TX
- Full-time
- 5 years
- Engineering
- Office
Quick Apply
10d
Sr. Mgr, Engineering - Design Quality (Onsite - Richardson, TX)
Collins Aerospace —Richardson, TX
- $132,400 - $251,600 a year
- Full-time
- 7 years
- Data analysis skills
- Travel
- Paid holidays
- Loan repayment program
Quality Control Lead Technician (Electronics OEM)
PriceVision Inc —Carrollton, TX
- Full-time
- Background check
- Management
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Quality Engineer Lead
PNC Financial Services Group —Farmers Branch, TX
- Full-time
- Spanish
- English
- Mid-level
- Wellness program
- Health savings account
6d

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Sr. Manager - Quality Assurance

Atrion Corporation | Halkey Roberts Corporation, Quest Medical, Inc., Atrion Medical Products -
Allen, TX

Quick Apply

Job Details

Full-time

Benefits

401(k) matching

Qualifications

ISO certification process
Staff supervision
Content creation for technical audiences
Defect resolution root cause analysis
Team supervision
Technical writing experience within manufacturing
Project management experience in manufacturing
Bachelor's degree
Biomedical regulatory compliance
Cross-functional collaboration
General management
FDA regulations

Full Job Description

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.

Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.

Summary:
The Sr. Manager of Quality Assurance leads the Quality Operations and Quality Engineering teams to ensure exceptional product quality and regulatory compliance. This role involves strategic project management to balance multiple projects with competing priorities. Key responsibilities include developing Quality Control Plans, utilizing data to enhance Quality Control and CAPA operations, and validating test methods. The manager reviews and approves critical documents such as Device History Records, SOPs, Validation Protocols, Deviation Reports, and CAPA Reports to ensure operational support and compliance.
Additionally, the Sr. Quality Assurance Manager manages environmental monitoring in production areas, oversees sterilization validation activities, and leads root cause analysis investigations for effective CAPA resolution. The role also involves qualifying and monitoring suppliers, deploying risk mitigations to ensure product safety, and participating in regulatory inspections and customer audits. Continuous innovation and improvement of testing methods and processes are essential aspects of this position.

General Duties and Responsibilities:

Manages and develops the Quality Operations and Quality Engineering leadership staff.
Utilize project management strategy at a department level to successfully execute multiple projects with competing resources and prioritization
Develops effective Quality Control Plans to assure world-class product quality.
Utilizes data as related to the Quality Control and CAPA operations.
Develops and validates test methods, performs data analysis, and writes/revises SOPs.
Reviews and approves documents, including Device History Records, Standard Operating Procedures, Validation Protocols and Reports, Deviations, Engineering Change Requests, and Non-Conforming Materials Reports, CAPA Reports, Complaint investigations and Supplier Corrective Action Reports to ensure operational support and compliance.
Manages the environmental monitoring program in applicable production areas, including sterilization validation and re-validation activities.
Leads root cause and failure analysis investigations to ensure effective CAPA resolution.
Continuously innovate and improve methods and processes. Defines optimum approaches in testing and analyzing data for each test being performed.
Acts as assistant to Management Representative during customer and regulatory audits. Participates in regulatory inspections and customer audits.
Qualifies new suppliers as needed and perform routine supplier monitoring activities.
Deploys effective risk mitigations to assure product safety and efficacy.

Qualifications:

Bachelor’s degree in a technical or scientific discipline is required.
A minimum of ten years of experience in a quality or regulatory position, preferably in the medical device industry. Experience with EO sterilization processes, sterile product assembly and packaging, and electronics assembly preferred.
A minimum of five years of management experience or 10 years in a quality leadership role.
Excellent working knowledge of the FDA’s 21 CFR Part 820; ISO 13485; EU Medical Device Directive (93/42/EEC); Canadian Medical Devices Regulation (SOR98-282); Japanese MHLW Ordinance 169; RDC ANVISA 16/2013, Australian TG(MD)R, ISO 14971, ISO 9001, and Medical Device Single Audit Program (MDSAP). Experience with IEC 60601 preferred.
Experience in supporting FDA inspections as a quality system subject matter expert and an ability to interpret regulatory requirements.
Detail oriented and possess a professional demeanor, be adaptable to changing environments, handle diverse workloads, and capable of completing tasks with little or no supervision.
Demonstrated ability to work in a highly cross-functional environment.
Excellent technical writing experience within a medical device environment is essential.
Strong root cause analysis skills.
Ability to use sound scientific judgement and risk management for the facility to prevent regulatory action.
The ability to work with minimal supervision to prioritize tasks and be able to manage several projects and tasks simultaneously to meet deadlines; and the ability to interface with all levels of management.
Certified Lead Auditor or ASQ certification as a Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) strongly preferred.

Notables / Benefits:

Summer hours available
Mid-size company with great company culture that is well diverse
Have a voice in the company
Average tenure for employee population is 7+ years
401k with employee matching available
Paid vacation and other excellent benefits

An Equal Opportunity Employer

Quick Apply

Refine Your Search

quality assurance manager jobs in allen tx

Sr. Manager - Quality Assurance

Home Loans Quality Assurance Team Manager- Vice President

Manager, Quality Assurance

Quality Assurance Manager

Project Manager – QA Automation

Manager, Quality Assurance

Quality Assurance Automation Manager

Associate Procurement Quality Manager

Supervisor Quality Control - DMX

Senior Manager, Data Quality & Issue Management

Regional Quality Manager

Quality Assurance Manager - Universal

Software QA Manager

Quality Manager

Manager, Regulatory Affairs and Compliance

Auto Ops Manager

Customer Quality Manager

Sr. Mgr, Engineering - Design Quality (Onsite - Richardson, TX)

Quality Control Lead Technician (Electronics OEM)

Quality Engineer Lead

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