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Compliance & Quality Program Lead

Greenlight GuruIndianapolis, Indiana, United StatesOnsite

Greenlight Guru empowers some of the world’s most innovative medical device companies to bring superior, life-changing products to market faster. Our leading SaaS platform, used by over 1,000 global customers, streamlines the entire product lifecycle—from concept and commercialization to post-market surveillance.
Based in Indianapolis, IN, Greenlight Guru is a remote-first company committed to improving lives. Since 2021, we've partnered with JMI Equity, a growth equity firm specializing in leading software companies, to further our mission of enhancing product quality and safety.

About this role:


As a Compliance & Quality Program Lead, you’ll work to assess regulatory requirements and accordingly establish governance and risk frameworks within Greenlight Guru. You will help build and run quality and security compliance programs to improve risk and compliance metrics. You will also develop and manage policies and standards.You will be part of a compliance-minded team that believes in progress and where a quality and security culture and mindset is key. You will be responsible for the support and implementation of scalable audit programs to support Greenlight Guru Infrastructure’s growth in regulated markets within the US and internationally.In this role you will create and coordinate documentation, tools, and processes for pre-audit readiness, audit testing, monitoring, and remediation activities.

Start with supporting audits and grow to lead them.

Your contributions and responsibilities: 


  • Drive quality in security assessments, audits, monitor and manage compliance of implemented quality and security controls to prepare and maintain requirements for ISO 9001, ISO 27001, SOC 2, and other frameworks
  • Provide oversight, for the development and maintenance of quality systems, programs, processes, and procedures that include
  • Creation and documentation of quality assurance activities
  • Support and develop systems for the identification, analysis, correction, and prevention of quality issues
  • Maintain system integrity by reviewing procedures for adherence to customer compliance, efficiency,y and industry best practices
  • Respond to customer security inquiries. Serve as a company representative with prospects, customers, and partners by assisting with completing security questionnaires, assessments, and audits
  • Evaluate and manage third-party risk and work with vendors to remediate identified risks
  • Manage periodic internal risk assessments based on changes to business, technology or threat landscape
  • Ensure that company policies are up to date, recorded, tracked, and disseminated to the entire company to minimize any quality, security, and/or compliance issues
  • Coordinate periodic disaster recovery/business continuity/incident response testing and training
  • Develop, maintain, and report against security control KPIs

Your ideal qualifications: 


  • Bachelor’s degree and 5+ years’ experience in the quality, audit, risk management, or similar field.
  • The ideal candidate will have experience managing quality and security assessments (ISO 9001, SOC2, ISO27001, GDPR) as an external or internal assessor.
  • Previous experience in a cloud environment, preferably AWS and/or Azure
  • Experience leading internal and/or external audits, working as the liaison between auditors and the business
  • Oral and Written Communication - Speaks and writes clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
  • Experience with documenting and tracking security risks
  • Proven ability to interview, gather, and understand content from subject-matter experts.
  • Strong organizational and problem-solving skills are required.
  • Strong project and time management skills are required.
  • Ability to work independently and as a team member is required.
  • Experience completing vendor questionnaires is a plus.

Benefits you’ll enjoy:


  • Supportive teammates and co-workers who care deeply about our mission
  • Flexible PTO and holidays
  • Home office stipend upon hire
  • Medical, dental, vision, life and disability benefits
  • 401k (with company match) 
  • Equity program eligibility (based on role and/or tenure)
  • Paid parental leave
  • Professional development allowance

This role will be based in Atlanta, Boston, Charlotte, Austin and Indianapolis. The base salary range for this role is $100,000-$120,000.  Actual base salary is determined by factors such as, but not limited to, experience, education, skills, and geographic location.  Certain roles may be eligible for incentive compensation and equity.  Greenlight Guru is an Equal Opportunity Employer. Individuals seeking employment at Greenlight Guru are considered regardless of race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.

If you need assistance or accommodations to submit your application for this position, please email careers@greenlight.guru.

Life at Greenlight Guru

Greenlight Guru is a modern quality management software platform built exclusively for the unique needs of the medical device industry. Our platform is currently being used by innovative medical device companies in over 600 cities and 50 countries on 6 continents to bring new products to market faster while simplifying regulatory compliance and reducing risk. Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality systems with Greenlight Guru. Being the only modern, industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes better allowing companies to innovate faster and be more efficient. To learn more about how we could help your device company or to demo our software, please visit https://www.greenlight.guru.
Thrive Here & What We Value- Remotefirst company- Commitment to DEIB- Highperforming, diverse, and inclusive environment- Innovation, fanatical support, true quality, closing- Best Place to Work
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