GelSight: Director of Compliance and Quality

Director of Quality & Compliance

General
Gelsight seeks an experienced and versatile Quality professional to lead compliance efforts.  This key position will provide company-level leadership of Quality and compliance across all products and services through oversight of a robust and integrated Quality Management System (QMS). Lead a Quality Team and guide the organization to ensure the design, implementation, and continuous improvement of quality system supports effective product development, manufacturing, and fulfilment across the product lifecycle.  This position requires regular presence in Waltham, Massachusetts, and reports to the Chief Operating Officer. 

Leadership

• Be the subject matter expert for applicable standards to serve existing and developing program and customer requirements.    
• Lead system definition and implementation to meet the rigor of internal and external compliance assessments.
• Lead programs/projects using standard project management tools and techniques for team coordination, tracking, and reporting.   
• Monitor and present product and system performance, trends, and risks to executive leadership, including KPIs and health metrics, to ensure stability and actionable plans to improve overall compliance.

• Partner with all functions of the business to ensure QMS integration with organization structure, company policies, and processes.
• Lead and support implementation of enterprise solutions (e.g. Document Management, CRM, ERP, PLM, MES, etc.) necessary to support a robust QMS.
• Ensure alignment between supplier quality systems and internal QMS expectations.

• Establish and maintain governance of core QMS elements in conjunction with department heads, including:

• Management Reviews and KPI Reporting
• Audits – Internal & External
• CAPA, Change Control, Deviations & Waivers
• Document Control and Records Management
• Training and Learning Management Systems
• Complaint handling and product quality assessments

• Lead and oversee writing/revising SOPs to meet relevant standards and key QMS elements.
• Spearhead the Compliance Team to ensure adequate assessment and management of gaps, internal and external audit findings, customer complaints, etc.
• Review and complete customer surveys, compliance questionnaires, and requests for information related to Gelsight’s products, QMS, and regulatory status.       
• Lead and provide oversight into QMS risk areas including facilitating risk assessments, post-mortems, and review of audit findings.
• Facilitate that audit reports and corrective actions are developed and completed within timelines mandated in internal procedures; utilize industry standard techniques (e.g. Six Sigma, 8D, etc.).
• Ensure audit and inspection findings are systematically trended within the QMS to drive systemic improvements.
• Escalate critical compliance risks to executive leadership.
• Educate and train company employees on key elements and responsibilities during system development, implementation, and maintenance.    

• Ensure generation and maintenance of product and part specific Quality Plans.
• Lead investigations into significant quality issues related to product and material including partnering with Product Management for MRB (Material Review Board) reviews and dispositions, identification of root causes, and development of appropriate corrective and preventive actions.
• Work with Engineering to develop and implement requirements for incoming, in-process, and final inspection and test of products within the materials management and production processes.          
• Own and facilitate the end-to-end process for customer returns from characterization closure including CAPA and ongoing analysis of data and trends.
• Integrate with Supplier Quality Engineering for a robust Purchasing and Supplier Oversight Program.

• 10+ years in Quality Management with emphasis on regulated-industry requirements within manufacturing.
• Minimum: BA/BS degree in Engineering or Business; Advanced degree is a plus.
• Experience leading a company through an ISO certification process (Gap Analysis through Certification).
• In-depth knowledge of ISO 9001 requirements in manufacturing companies
• Proven experience designing, implementing, or transforming enterprise QMS frameworks.
• Experience in managing, hosting, and supporting customer audits and inspections.
• Excellent understanding of the deliverable and stages of the New Product Introduction process.
• Demonstrated leadership skills and experience in managing Quality Teams.
• Strong communication and interpersonal skills, capable of effectively collaborating with cross-functional teams and external stakeholders.
• Strong problem-solving and decision-making abilities, with a continuous improvement mindset.
• Relevant certifications are desirable.