Brio Group · 2 weeks ago
Vice President of Quality
Brio Group is seeking a Vice President of Quality Assurance who will lead the company's quality strategy and execution. This role involves ensuring regulatory compliance, product safety, and operational excellence while building and leading a high-impact quality organization.
Responsibilities
Own and evolve the organization’s quality management system in alignment with U.S. and international medical device regulations
Serve as the senior quality leader interacting with regulatory authorities and external auditors
Ensure audit readiness and effective execution of regulatory inspections and third-party assessments
Oversee complaint handling, post-market surveillance, and corrective and preventive action activities
Lead, mentor, and scale a high-performing quality organization
Foster a culture of accountability, collaboration, and continuous learning
Partner with operations, engineering, and executive leadership to align quality objectives with business goals
Provide quality leadership from early concept through commercialization
Embed risk-based thinking into design, development, and manufacturing processes
Ensure quality systems are efficient, scalable, and supportive of innovation
Establish quality metrics and use data to drive decision making and improvement initiatives
Lead efforts focused on process optimization, defect reduction, and operational excellence
Ensure timely resolution of quality issues to minimize regulatory and business risk
Drive initiatives that ensure products meet high standards for safety, reliability, and performance
Leverage customer feedback and post-market data to strengthen product quality and brand reputation
Promote quality awareness and engagement across the organization
Qualification
Required
Bachelor's degree in Engineering, Science, Regulatory Affairs, or a related discipline (or equivalent experience)
Significant senior-level experience leading quality and/or regulatory functions in the medical device industry
Deep expertise with U.S. and international quality system regulations and standards
Proven track record of building and improving quality systems in fast-paced, evolving environments
Strong executive presence with the ability to influence across functions and at the leadership level
Hands-on, pragmatic leadership style with strong attention to detail
Excellent communication skills, including the ability to clearly convey risk, strategy, and performance
Benefits
Strong compensation
Bonus
Equity
Company
Brio Group
"Hire Possibilities" Brio Resource Group - Your biopharmaceutical recruiting experts - is transforming the way today's most sought after "A" Talent is introduced and placed in strategic roles with desirable companies.
Funding
Current Stage
Growth StageTotal Funding
$0.26MKey Investors
National Science Foundation
2022-06-01Grant· $0.26M
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