Quality Leader

Quality Leader

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 fulfilling, 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, 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.

Preferred Education and Experience:

• 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).

Work Environment:

The team member's essential job duties require the team member to spend his/her time in an office environment. The team member must be able to correctly wear and use any Personal Protective Equipment (PPE) required by the employer when in the manufacturing area.

Position Type:

This is a regular, full-time position with the understanding that a regular workweek may require extended days and hours as needed to meet business needs. Must be able, available, and willing to work more than 40 hours per week, including scheduled and unscheduled overtime.

Physical Demands:

The physical demands described here are representative of those performed in the job duties. Performing the role frequently uses close vision, speech, hearing, frequent standing, use of hand tools and dexterity to work with equipment as may be needed.

Travel:

Limited travel is required for this position, up to 15%.

At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process. Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company:

Carr Biosystems