Manager, Data Analytics

Role Overview

• 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
• 401(k) plan
• employee assistance program
• Employee Stock Purchase Plan
• paid time off (including sick time)
• paid Holidays