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Regenesis · 3 days ago

Director of Quality

Scottsdale, AZ

Full-time

Hybrid

Director/Executive

10+ years exp

Regenesis is transforming digital health care with disruptive technology. The Director of Quality is responsible for developing and sustaining the company-wide Quality Management System, ensuring compliance and continuous improvement in alignment with business objectives.

BiotechnologyHealth CareMedical DeviceWellness

Hiring Manager

Kay Bredvik

Responsibilities

Develop and execute the enterprise quality strategy in alignment with business goals, regulatory requirements (FDA QMSR, ISO 13485), and long-term organizational growth

Serve as the company’s management representative for the Quality Management System

Make high-impact compliance, risk, and quality decisions affecting the entire organization

Proactively identify and mitigate compliance and quality risks across product lifecycle, operations, suppliers, and post-market activities

Own and ensure the effectiveness, compliance, and continuous improvement of the company-wide QMS, including but not limited to; design controls and design transfer, manufacturing and production quality, CAPA, complaints, and nonconformances, Document control, training, and change management, Supplier quality and external partnerships, Validation, verification, and quality records

Define, monitor, and optimize enterprise-level quality metrics and management review processes

Ensure sustained audit readiness and compliance for all internal, customer, and regulatory audits

Lead, develop, and manage the entire quality organization, including staffing, onboarding, coaching, performance management, and succession planning

Own and drive cross-functional quality initiatives across the organization

Advise executive leadership and key stakeholders on quality, compliance risk, and regulatory strategy

Set and champion a company-wide culture of quality by aligning leaders on expectations, modeling quality-first decision-making, and reinforcing sound compliance behaviors

Lead all external regulatory inspections, third-party audits, and customer audits

Ensure effective responses to audit findings, regulatory observations, and compliance issues

Maintain strong working relationships with regulatory agencies and notified bodies, as applicable

Drive continuous improvement initiatives focused on quality system maturity, operational excellence, and risk reduction

Partner with Operations, R&D, Supply Chain, Regulatory, and Commercial teams to ensure quality is integrated into business processes and decision-making

Ensure quality systems scale effectively with business growth and evolving regulatory expectations

Qualification

FDA QMSRISO 13485Quality Management SystemInternal auditingExternal auditingRegulatory complianceProject managementSuccession planningCoachingPerformance managementQuality culture advocacyRisk reductionProblem-solvingCommunication skillsNegotiation skillsTeam playerFlexibilityOrganizational abilitiesSelf-starterLeadershipCross-functional collaboration

Required

Bachelor's degree in Engineering or related technical field

10+ years of experience in quality or manufacturing within a regulated industry (medical device preferred)

Demonstrated experience leading and maintaining FDA QMSR and ISO 13485 compliant quality systems

Internal and external auditing experience

Proven ability to lead high-complexity, high-risk quality initiatives across an organization

Flexibility, strong problem-solving skills, project management, planning, and organizational abilities

Excellent written and oral communication skills, negotiations skills with ability to drive cross functional teams

Self-starter and team player able to work with individuals at all levels in the organization

Preferred

Project management training and/or certification (CAPM, PMP)

Certified Manager of Quality/Organizational Excellence (CMQ/OE)

Certified Supplier Quality Professional (CSQP)

Company

Regenesis

Regenesis is a device company dedicated to improving human welfare through the research, design, manufacture, and sale of energy-based medical products and services that alleviate pain to improve quality of life.

Founded in 1997

Scottsdale, Arizona, USA

51-200 employees