Quality Manager

Overhaul Group Inc•Austin, TX

39d

About The Position

As a Quality Manager, you will be responsible for establishing, implementing, and ensuring continuous improvement of the organization’s Quality Management System (QMS). This role provides strategic leadership, operational oversight, and cross-functional coordination to ensure compliance with applicable standards, regulatory requirements, and internal business governance. In this role, you will drive key initiatives through engagement with internal and external partners to meet strategic objectives and targeted outcomes. You will lead the formation of workstreams to ensure process simplification, adoption, and operationalization, while establishing metrics to measure performance and ensure continuous improvement.

Requirements

Bachelor’s Degree in a relevant field (Quality, Engineering, Life Sciences, Operations Management, Business or similar)
5+ years of experience in Quality Assurance working with Pharma, Life Sciences and/or Biotech
5+ years of experience leading global teams
Demonstrated experience managing an ISO 9001 aligned QMS
Ability to travel up to 10% (domestic and international)

Nice To Haves

Master’s degree addressing strategic planning (Quality, Operations, Technology or similar)
Knowledge of GxP, ISO 9001, 21 CFR Part 11, EU Annex 11, ISO/IEC 17025
Experience in cold chain / supply chain monitoring or medical device industries
Experience with implementing and managing eQMS systems
Experience with validating software and hardware systems for support of regulated environments
Strong organization skills, with ability to lead multiple initiatives
Strong team leadership and communication skills
Strong problem solving and analytical skills
Experience collaborating with external partners
Experience in SaaS solutions or technology driven environments

Responsibilities

Build and mentor a high‑performing quality team to ensure effective ownership and execution of the QMS.
Develop and execute the organization’s QMS strategy, roadmap, and governance model, inclusive of the evaluation and implementation of an eQMS system.
Collaborate with partners to architect scalable, audit‑ready frameworks, including document control, training, CAPA, risk management, internal and external audits, and management review.
Ensure alignment of QMS activities with organizational goals, customer requirements, and regulatory expectations.
Lead internal communication strategies to promote quality culture, process adoption, and organizational alignment.
Maintain compliance with ISO 9001 and other relevant standards or regulations.
Establish quality objectives, KPIs, and monitoring mechanisms to measure system and process performance.
Oversee internal and external audits, ensuring findings are addressed through effective corrective and preventive actions.
Develop and oversee the supplier evaluation and performance monitoring program, ensuring criteria, risk ratings, and approval status are maintained.
Manage external communications with customers, auditors, and regulatory bodies regarding quality matters.
Work with Product, Engineering, Operations, Customer Support, and other teams to embed quality practices into daily operations.
Facilitate cross‑functional problem‑solving, root cause analysis, and continuous improvement initiatives.
Provide guidance and coaching to process owners to ensure QMS adoption and accountability.
Drive a culture of quality, operational excellence, and proactive risk management.
Identify opportunities to streamline processes, reduce waste, and improve system maturity.
Leverage data, metrics, and audit insights to guide improvement initiatives.
Oversee the creation, approval, revision, and retention of controlled documents.
Ensure documentation is consistent, traceable, and aligned with QMS architecture.
Develop templates, workflows, and document governance structures.
Develop and deliver QMS training programs to ensure organizational understanding and compliance.
Lead change management efforts related to new products, processes, tools, and quality initiatives.
Ensure employees understand their roles in maintaining quality and compliance.