Quality Leader

About Us:

CARR Biosystems is a growing business providing critical technology for cutting-edge life science innovations. Our customers are inventing tomorrow's solutions to treat and cure disease, and our centrifuge technology is enabling it. We're part of a $3.3 billion parent company (Barry-Wehmiller) where culture is a priority. Our goal is to have performance and people in harmony - and we believe work should be fun, we should inspire our teammates, and each team member is someone's precious child.

We feel it's a unique opportunity to build the future of CARR Biosystems. If this excites you, please read on…

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description:

CARR Biosystems is a growing business providing critical technology for cutting-edge life science innovations. Our customers are inventing tomorrow's solutions to treat and cure disease, and our centrifuge technology is enabling it. We're part of a $3B parent (Barry-Wehmiller) where culture is a priority. Our goal is to have performance and people in harmony - and we believe work should be fufilling, we should inspire our teammates, and each team member is someone's precious child.

We feel it's a unique opportunity to build the future of CARR.

The Quality Leader is responsible for leading and overseeing the organization's quality management system to ensure products and processes consistently meet internal standards, customer requirements, and applicable regulatory and ISO requirements. This role provides strategic and operational leadership for quality assurance and quality control activities, drives continuous improvement initiatives, and partners cross‑functionally to support operational excellence.

Principal Duties and Responsibilities:

* Lead and manage the Quality organization, including quality assurance and quality control activities, to ensure compliance with established quality standards, policies, and procedures.

* Provide leadership, coaching, and performance management for quality team members; ensure appropriate training and development.

* Direct ownership of incoming inspection, customer complaint resolution, quality assurance strategy & procedures, and ISO 9001 and other compliance.

* Oversee ongoing manufacturing QA/QC in ISO 7 cleanroom operations and monitoring.

* Partner with Manufacturing, Engineering, Supply Chain, and Field Service teams to embed quality into operational processes and support continuous improvement initiatives.

* Monitor and analyze quality metrics and KPIs, reporting trends, risks, and improvement opportunities to leadership.

* Develop, implement, and maintain quality management systems, processes, and documentation in alignment with ISO 9001 and other applicable regulatory or customer requirements.

* Ensure effective inspection, testing, and monitoring of products, materials, and processes to verify conformance to specifications.

* Drive root cause analysis and corrective and preventive action (CAPA) processes to address nonconformances and quality issues.

* Lead internal and external audits, including preparation, execution, and follow‑up actions.

* Enforce regulatory, safety, and quality compliance across all applicable operations.

* Perform other duties as assigned to support business objectives.

Required

Education and Experience:

* Bachelor's degree in related field (Engineering, Quality, Life Sciences, or a related technical field)

* Minimum of 5 years of progressive experience in a quality leadership or quality management role within a manufacturing or regulated environment.

* Demonstrated ability to develop risk-based quality assurance and control.

* Demonstrated experience with ISO‑based quality management systems (ISO 9001 required, ISO 13485 desired).

* Strong knowledge of quality systems,…