Senior Quality Management Systems (QMS) Manager

Quick Facts

• Role: Senior Quality Management Systems (QMS) Manager

• Travel: Up to 25%

• Scope: Global medical device QMS governance, compliance, audits, supplier quality, and digital quality systems across multiple sites

Description

Lead and continuously improve a compliant, effective, inspection-ready global medical device Quality Management System. This role provides governance for QMS compliance and execution across sites, including Supplier Quality, internal audits, and electronic/digital quality systems, while driving continuous improvement using metrics and risk-based decision-making.

Responsibilities

• Lead global QMS governance, harmonization, and continuous improvement across sites and functions.
• Lead regulatory and standards surveillance, gap assessments, and implementation of new or revised requirements.
• Govern core QMS processes: CAPA, change management, document control, training, Management Review, and quality metrics.
• Oversee the Supplier Quality Program: qualification, monitoring, performance, SCARs, and supplier risk.
• Lead the Internal Audit Program: planning, auditor qualification, execution, reporting, and follow-up.
• Implement and optimize electronic QMS and Document Control systems within the ERP/eQMS environment.
• Provide quality oversight for computer software assurance/validation of quality-impacting systems.
• Drive QMS performance, inspection readiness, and continuous improvement using metrics, trends, and risk-based decisions.
• Serve as a senior QMS SME during FDA, Notified Body, MDSAP, certification, and customer audits.
• Oversee quality processes supporting customer information requests and change notifications.
• Lead, coach, and develop the QMS team; partner with site and functional leadership to drive Quality System effectiveness.

Requirements

• Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or related technical discipline.
• 10+ years of Quality experience in medical device or regulated life sciences.
• 5+ years leading QMS programs or major Quality System initiatives.
• 5+ years people-management experience.
• Advanced knowledge of ISO 13485 and FDA medical device QMS requirements.
• Experience with global regulatory requirements and regulatory/standards gap assessments and QMS implementation.
• Strong experience with core QMS processes and Supplier Quality Program governance in a manufacturing environment.
• Experience with regulatory inspections, Notified Body audits, MDSAP, and/or certification audits.
• Demonstrated ability to lead complex, cross-functional, multi-site initiatives.
• Strong leadership, analytical, communication, technical writing, and problem-solving skills.
• Global or multi-site medical device QMS experience.
• Knowledge of EU MDR and medical device requirements in Canada, Australia, Brazil, Japan, Switzerland, and the UK.
• Experience with eQMS/ERP Quality systems, software assurance/validation, and ISO 14971 risk management.
• Lead Auditor / ASQ CMQ/OE / CQA / RAC or equivalent certification preferred.

Benefits

• Expected pay range (at commencement): $152,800–$175,000 (base pay may vary based on market location, knowledge, skills, and experience)

• Total compensation includes: medical, prescription drug, dental, and vision insurance; flexible spending accounts; participation in a 401(k) savings plan; and paid time off (PTO, short- and long-term disability, parental leave)