Senior Manager, Quality Assurance

Dentsply Sirona

. Lead Quality and Regulatory Compliance activities for the site .

Posted 9/23/2026full-timeYork • Pennsylvania • United StatesSenior💰 $166,750 - $195,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality and Regulatory Compliance within the life sciences sector, particularly in medical devices, with a strong focus on FDA and ISO standards. Proven ability to lead teams, manage quality assurance programs, and drive continuous improvement initiatives.

Highest-signal resume keywords

Quality Assurance Program ManagementRegulatory Affairs LeadershipFDA and ISO 13485 ComplianceLEAN Principles ImplementationSix Sigma Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submissions PreparationQuality Metrics OversightCAPA ManagementData Analysis for Decision-MakingSupplier Quality Management

Soft Skills

Leadership and CoachingExcellent Communication SkillsOrganizational SkillsCustomer-Focused Orientation

Tools & Technologies

Microsoft Office

Certifications & Qualifications

Six Sigma Certification

Industry Keywords

Quality and Regulatory ComplianceMedical DevicesMDD/MDRCMDCASPMDATGACTD DocumentsChange ManagementInternal Audit ProgramTechnical File for CE Marking

About the role

Key responsibilities & impact

Lead Quality and Regulatory Compliance activities for the site
Implement, manage, and sustain the site-wide quality assurance program
Ensure conformity with FDA, ISO 13485, MDD/MDR, CMDCAS, PMDA, TGA, and other applicable requirements
Oversee Regulatory Affairs for pharmaceutical products
Manage, coach, and develop Quality and Regulatory associates
Manage site external audits and audit finding responses, corrective actions, and follow-up
Develop systems to measure and improve quality and regulatory compliance
Review and approve product labeling changes and marketing/promotional literature
Support LEAN and Change Management activities
Manage quality and regulatory documentation, records, and retention controls
Oversee the internal audit program and corrective actions
Manage supplier quality, product/process change control, complaint management, CAPA, and nonconformance systems
Oversee the site Management Review process and quality metrics
Support Product Group design control activities and review design control documentation
Oversee Technical File documents for CE marking
Prepare US regulatory submissions, including 510(k)s, and support Canadian and international registrations
Ensure timely delivery of pharmaceutical CTD documents, including CMC content
Drive cross-functional teams across senior levels and regions

Requirements

What you’ll need

Bachelor’s degree or equivalent in science or engineering
5+ years in a leadership role in quality/regulatory in life sciences, preferably medical devices
Proficient in Microsoft Office-based systems
Ability to use data for presentations and decision-making
Comprehensive understanding of lean principles and experience implementing them in an operational environment
Business acumen to analyze data and trends
Ability to motivate, train, coach, mentor, and lead direct reports
Excellent oral and written communication skills
Strong organizational skills and attention to detail
Customer-focused orientation
Ability to travel up to 10%
Ability to prepare and manage an annual site department budget
Ability to develop business cases for CapEx investments
Six Sigma certification preferred

Benefits

Comp & perks

Professional development opportunities
High-performance, empowering culture
Equal employment opportunity
Disability accommodation during the application process