Provides independent guidance to business partners on quality data handling and analytics.
Establish dashboards and data visualizations to support product quality and continuous improvement.
Leads metrics and data analytics work for Complaints, Recalls, NC, CAPA, Audits/Compliance and other areas of Quality.
Ability to manage complaint trending activities and related software system validations.
Ability to compile and present quality data and analysis to the business eg: Management Review.
Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives.
Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.
Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.
Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency.
Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS).
Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.
Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements.
Coach and mentor emerging Quality team members to build organizational capability and ensure robust succession planning.
Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders.
Ability to identify and drive process improvements; own process investigations, nonconformance records or corrective actions in response to audit findings.
Requirements
Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.
7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership.
Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
Proven ability to lead and develop high-performing teams and build future technical and people leaders.
Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
Experience leading in a matrixed, global organization and managing competing priorities effectively.
Commitment to scientific integrity, compliance excellence, and continuous improvement.
Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline preferred.
Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools preferred.
Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise preferred.
Experience supporting or leading Health Authority or Notified Body inspections preferred.
Tech Stack
PMP
Benefits
medical, dental, vision, life, and disability insurance