Evergen · 14 hours ago
Quality Director
West Lafayette, IN, US
Full-time
Onsite
Director/Executive
$130K/yr - $190K/yr
10+ years expEvergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. The Quality Director will provide strategic direction and leadership for the QA and QC teams, ensuring compliance with regulatory requirements and driving continuous improvement initiatives to enhance product quality and manufacturing processes.
Medical DeviceHealthcareManufacturingHealth CareIndustrial ManufacturingProduct Design
Responsibilities
Provide strategic direction and leadership for the QA and QC teams, ensuring compliance with regulatory requirements and industry standards including, but not limited to 21 CFR 820 and 211, ISO 13485, MDSAP, and ISO 14971
Analyze data and metrics to identify areas for improvement and implement corrective/preventive actions. Drive continuous improvement initiatives to enhance product quality, reduce defects, and improve manufacturing processes
Work closely with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure quality standards are met throughout the product lifecycle
Ensure timely completion of quality-related projects and activities, supporting overall project timelines and goals
Maintain a state of audit readiness, ensuring all quality systems and processes are compliant with regulatory requirements and prepared for internal and external audits. Represent the QMS internally (Site Lead) and to external entities/partners
Provide thought leadership and guidance to all site teams, fostering a culture of quality and continuous improvement
Oversee the development and maintenance of quality documentation, including SOPs, work instructions, and quality records
Collaborate with Corporate Training department to develop and implement training programs to ensure all employees are knowledgeable about quality standards and procedures
Identify and mitigate quality risks, ensuring proactive measures are in place to address potential issues
Qualification
Required
Bachelor's degree in relevant discipline
10+ years of experience in the medical device or biologics industry
7+ years of leadership experience
Excellent verbal and written communication
Microsoft Office Suite, intermediate Excel
Statistical techniques
Problem-solving methodologies
Technical writing
Quality Management System (QMS) software
Up to 20% of travel may be required
Move or lift objects up to 25 pounds
Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
Office environment with assigned workstation
Benefits
Annual Bonus eligibility: $40,000
Company
Evergen
Evergen provides biomaterial development, manufacturing, and donor tissue processing services.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2017-08-03Acquired
Leadership Team
Chad Croasdale
Chief Commercial Officer (CCO)
Recent News
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