Overview
Performance Quality Auditor II Jobs in Indianapolis, IN at Elevance Health
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women’s healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women’s health care clinicians. More information can be found at www.coopersurgical.com .
The Quality Assurance Manager plays a critical role in ensuring compliance with quality standards and regulatory requirements at the Dallas-Fort Worth Distribution Center. This position is responsible for overseeing Quality Assurance processes within the medical device distribution environment, ensuring adherence to Good Manufacturing and Distribution Practices (GMP/GDP), ISO 13485 standards, and company quality and regulatory policies. This is a key leadership role within the Distribution Center Operations, responsible for managing the quality team, enhancing the effectiveness of the Quality Management System (QMS), and driving continuous improvement initiatives. Additionally, serves as the primary point of contact for quality compliance, spearheading quality system enhancements to support operational excellence and regulatory alignment within the Distribution Center. Will also engage with the broader Global Quality Operations team.
Bachelor’s degree in quality assurance, engineering, life sciences, or a related field is required.
Certifications in Quality System, ISO 13485, and Lead Auditor are preferred.
Minimum of 5 years of experience in Quality Assurance or a related field within the medical devices distribution, pharmaceuticals, or life sciences industry.
Minimum 5 years in management or leadership role, overseeing distribution or logistics operations is a plus.
Experience with cold chain management and temperature monitoring systems is a plus.
Experience in supporting audits, CAPA management, and risk assessments are preferred.
Demonstrated leadership capabilities with a proven track record of effectively managing and developing high-performing quality teams.
Proficiency in Microsoft Office Suite, D365 ERP, and other relevant applications is preferred.
Experience in healthcare, medical devices, or other regulated industries operating under FDA regulations is highly preferred.
Results-driven, innovative, creative, and action-oriented; capable of aligning and energizing teams around common objectives within both reporting and non-reporting structures.
Demonstrates strong critical thinking and decision-making skills, with the ability to solve complex problems and develop innovative solutions that drive results for the organization.
Travel : This role may require up to 15% travel including domestic and international.
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Lead and manage the Quality Assurance team, ensuring daily tasks are executed effectively, efficiently, and on time.
Foster a culture of quality and continuous improvement, encouraging engagement, accountability, and best practices within the distribution center.
Develop strategic goals and objectives for the Quality Assurance department, continuously improving the Quality Management System (QMS) to enhance compliance, efficiency, and Good Distribution Practices.
Establish key performance indicators (KPIs) to measure team performance, quality assurance metrics, and compliance effectiveness.
Maintain a comprehensive training matrix and records to ensure compliance with training requirements for all Distribution Center personnel, including those directly and indirectly involved in quality-related processes.
Prepare and present quality performance reports to senior management, providing insights into trends, risks, and improvement opportunities.
Managing the Incoming Quality Control process, ensuring accurate quality order inspections, documentation control, timely release, and compliance with quality requirements.
Manage the Return Material Authorization (RMA) process, ensuring returned materials are inspected, documented, and appropriately dispositioned. Coordinate with internal teams to resolve RMA issues effectively.
Oversee product holds and quarantine processes, ensuring the appropriate handling, investigation, and disposition of defective, nonconforming, or suspect products in accordance with regulatory and company guidelines.
Ensure compliance with ISO 13485 standards and regulatory requirements by overseeing the implementation, maintenance, and enhancement of the Quality Management System (QMS).
Manage document control processes, ensuring accurate updates, approvals, and maintenance of procedures, work instructions, and records.
Plan and conduct internal audits, ensuring timely resolution of audit findings and proactive improvements to prevent recurrence.
Manage Corrective and Preventive Actions (CAPA) processes, ensuring timely closure and effectiveness verification.
Provide training, coaching, and performance evaluations for quality personnel to develop a high performing, engaged team.
Collaborate cross-functionally with Warehouse Operations, Supply Chain, Procurement, Manufacturing, Customer Service, Sales, and other departments to address quality concerns and drive continuous improvement initiatives.
Oversee and conduct non-routine inspections, addressing and resolving any findings or deviations as necessary.
Develop, review, and approve Standard Operating Procedures (SOPs) to ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and company quality standards.
Monitor adherence to quality policies and procedures, providing training and guidance to ensure regulatory and operational compliance.
Identify and implement process improvements to enhance operational efficiency, mitigate errors, reduce quality cost, and maintain good distribution practices & quality standards.
Analyze quality data, metrics, and trends to develop strategies for reducing nonconformances and improving quality assurance practices.
Drive initiatives to streamline quality assurance processes, ensuring cost-effectiveness while maintaining high-quality standards.
Conduct risk assessments and mitigation planning for quality-related processes to minimize potential compliance risks.
Participate in supplier contract reviews, including the evaluation and approval of Quality and Supplier Agreements, ensuring adherence to regulatory and business requirements.
Lead cross-functional projects to enhance cold chain management, optimize temperature monitoring systems, and improve product handling conditions throughout the distribution process.
Supervise the monitoring and calibration of the Temperature Monitoring System in all temperature-controlled areas of the distribution center to ensure compliance with storage requirements for medical devices.
Communicate updates on quality standards to internal teams and key stakeholders to ensure organizational alignment.
Ensure the implementation, enforcement, and continuous management of all quality policies and procedures throughout the distribution center’s operations.
Collaborate with all business functions to develop and implement strategies that continuously improve customer experience while ensuring compliance with regulations and Good Distribution Practices (GDP).
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Title: Performance Quality Auditor II
Company: Elevance Health
Location: Indianapolis, IN
