Quality Leader

Barry-Wehmiller•Clearwater, FL

About The Position

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.

Requirements

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, auditing, CAPA, and regulatory compliance.
Excellent analytical, problem‑solving, and decision‑making skills.
Strong written and verbal communication skills with the ability to communicate at all organizational levels.
Ability to lead change, manage priorities, and operate effectively in a fast‑paced environment.
Proficiency with quality systems, documentation tools, and standard business software.

Nice To Haves

Master’s degree in a related field
Experience in life sciences, medical device, or cleanroom quality and manufacturing environment (ISO 13485).
Proven ability to lead teams, influence cross‑functional partners, and drive continuous
Formal training or certification in quality methodologies (Lean, Six Sigma, or equivalent).

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.