Summary
Overview
Work History
Education
Skills
Timeline
Generic

T-Max Barlue

Brooklyn Park,MN

Summary

Highly-skilled Director of Quality Assurance with comprehensive experience in developing and implementing quality assurance strategies. Strengths include adeptness at identifying process inefficiencies, fostering a culture of continuous improvement, and leading cross-functional teams to enhance product quality. Demonstrated success in delivering tangible improvements in previous roles, contributing significantly to the enhancement of customer satisfaction and business performance.

Overview

8
8
years of professional experience

Work History

Director of Quality Assurance

Streamworks
Blaine, MN
06.2023 - Current
  • As the Senior Director, Quality Assurance & Quality Systems, you will provide leadership in the development, implementation, and maintenance of CVRx’s quality assurance systems and activities
  • You will be in charge of defining and specifying the implementation of standards, methods, processes, quality training, quality programs and the quality auditing of the CVRx’s products, processes, and services
  • Through leadership, knowledge, and communication, the Senior Director of Quality Assurance & Quality Systems is a driving force in the company’s pursuit of excellence in all aspects of our company
  • Serve as the management representative to the quality system
  • Oversee quality systems to include change control, vendor qualification, records management, equipment and process validation, training and competency program and documentation, internal and external audits, standard operating standards (SOPs), process improvement, change control, and data review support
  • Facilitate the development and update of corporate quality policies and auditing practices as well as authorize their implementation
  • Manage the successful ISO 13485 and MDSAP certification and ensure the certification remains intact; including U.S. QSR 21 CFR 820 requirements and other country requirements as we enter into those markets
  • Assist organizations throughout the company to identify, document, and implement Quality Systems, including policies, processes, procedures, work instructions, and forms that ensure compliance to U.S. QSR 21 CFR 820, ISO 13485, EU MDR, and other worldwide regulatory requirements where devices are being marketed
  • Assist these organizations in the development and updates of departmental performance scorecards
  • Schedule and lead regular management reviews per SOP requirements
  • Coordinate, collaborate, and communicate both internally and with our customers and suppliers to resolve problems/complaints and execute projects in a timely and effective manner
  • Develop key quality assurance metrics and provide routine management reporting and coordinated corrective and preventive action (CAPA) plans to address areas of deficiencies
  • Ensure training, as related to quality systems, procedures, and operator certification is effective and completed

Director of Quality Improvement

Shutterfly
Shakopee, MN
11.2021 - 06.2023
  • Establish and lead a team of Lead System Integrators (LSIs) supporting research and development (R&D) project management work and facilitates technical decision making for pharmaceutical products, medical devices, and other regulated healthcare products
  • Establish and continuously improve relevant operating mechanisms to drive organizational accountability, aggressive project execution, and diligent technical rigor
  • Ensure LSI organization accountability for R&D focused program schedule creation, tracking, and execution
  • Responsible for strategic portfolio management for all projects supported by the Drug Products and Sciences organization
  • Establish and drive maintenance of on-market product roadmaps in collaboration with R&D product design owners (PDOs) and cross-functional interfaces
  • Accountable for R&D team project performance, program schedule commitments, budget commitments and spend
  • Leads team in defining program strategies, developing goals, and facilitates cross-functional decision making through structured, best-practice processes
  • Provides clear direction on product lifecycle management requirements to meet expectations of external customers and business stakeholders
  • Interacts through program updates and reviews with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders
  • Ensures identification, escalation, and communication of project risks, development of risk assessment/mitigation plans and proactive management of risk response strategies
  • Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes
  • Maximizes business results through continuous improvement in organization's ability to execute programs from identification through implementation
  • Participates as a member of cross functional teams and/or integrates cross functional inputs into project delivery
  • Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards

Quality Assurance Manager

SSAB
Roseville, MN
02.2018 - 11.2021
  • Implement where necessary and maintain Windings’ Quality Management System in compliance and certified to AS9100/ISO 9001.
  • Establish and maintain quality certifications such as NADCAP as required by customers.
  • Lead and manage a skilled quality team. This includes providing day-to-day communication and guidance, goal setting, performance feedback, on-going training, discipline, and documentation of relevant events and occurrences.
  • Establish quality metrics and ensure employees’ understanding of key quality metrics and continual improvement targets.
  • Develop and implement key processes for preventive and corrective action and improving the company ability to meet quality, cost, and delivery targets
  • Manage development of procedures and practices for sampling and inspection plans, root cause analysis, calibration of equipment, etc.
  • Direct and oversee communication with customers and/or customer service regarding customer returns.
  • Lead and manage continuous improvement of process, product and service quality levels including working closely with cross functional teams to determine root cause and proposed solutions.
  • Work with other departments to ensure delivery to customer’s expectations, including product quality, production output, cost reduction, documentation requirements, and quality system compliance.

Senior Quality Control Specialist

Sabre Industries
Sioux City, IA
07.2016 - 02.2018
  • Serves as a “Working Lead Person”
  • Must be able to perform all inspection functions except nondestructive testing. (Able to take over inspectors activities).
  • Communicate instructions from management in a detailed manner on a daily basis.
  • Responsible for training and development of all inspectors.
  • Ensure that all documentation is accurately and neatly completed.
  • Responsible for holding safety and all other meetings with team members in order to communicate important information at the beginning of each shift.
  • Keep pass down log accurate.
  • Ensure that all inspectors are complying with Sabre Tubular Structures safety standards.
  • Able to assume responsibilities of the QC supervisor when needed.
  • Maintain a professional demeanor at all times.
  • Regular and on-time attendance.
  • Work in your shift as scheduled.
  • Must work well with others.
  • Additional duties as assigned.

Education

MBA - Organizational Leadership

Eastern University
Wayne, PA
12-2034

Skills

  • Quality Management
  • Corrective Action Planning
  • Six Sigma principles
  • Customer Service
  • Product Inspections
  • Process Documentation
  • Team Collaboration
  • Product Testing
  • Specification Review
  • Product Development
  • Performance monitoring

Timeline

Director of Quality Assurance

Streamworks
06.2023 - Current

Director of Quality Improvement

Shutterfly
11.2021 - 06.2023

Quality Assurance Manager

SSAB
02.2018 - 11.2021

Senior Quality Control Specialist

Sabre Industries
07.2016 - 02.2018

MBA - Organizational Leadership

Eastern University

Similar Profiles

CREATE PROFILE
T-Max Barlue