Manager, Quality Systems

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Job Overview This role is responsible for leading quality‑related initiatives, i.e. MQRB and Regulatory Audits, including identifying quality deliverables as outlined in the Quality Processes. The position plays an important role in enabling regulatory readiness and serves as the Backroom Manager during audits and inspections.  You are responsible for leading and directing the workload of Quality System (QS) projects as required with key quality deliverables as specified.

This role is responsible for managing the timelines for QS initiatives including audit programs, responses, QMS compliance efforts, and system-level improvements to ensure adherence to FDA and global regulatory standards. This role is to manage the QMS elements, while supporting the implementation and deployment of Quality Process enhancements. In this role, you will use your experience or expertise to develop and deliver on quality requirements, solve problems, influence a quality minded culture, develop and execute objectives for self and others, and be able to effect short-term and long-term /business goals.

Contribute to continuous improvement initiatives to enhance quality project delivery and operational effectiveness.

Job Responsibilities and Essential Duties Work with the Quality System (QS) team to develop and maintain timelines and milestones for assigned Quality initiatives by leading and managing the following Quality elements:

Management System Plans (MSPs) – Issuance, review, monitoring of actions and tracking status to closure.

External Audit Program and the coordination of responses.

Work with QS team to define scope, deliverables, timelines, and milestones for QMS elements to completion.

Develop and maintain QMS updates and progress to completion

Work with Program Management to align resources impacting quality projects.

Ensure alignment of projects within the QMS requirements and regulatory agency expectations

Drive continuous improvement of Quality Systems processes and tools

Partner with site Quality, Regulatory, Program Management, Engineering, Manufacturing, and Operations teams, as well as appropriate Global functions.

Audit Management Serve as Backroom Manager for External audits (FDA, Notified Bodies, Customers, etc.)Coordinate audit logistics, training, documentation readiness, and subject matter expert (SME) support

Lead post-audit activities including observations and commitments tracking

Governance & Reporting Generate status updates.

Work with PMO regarding overall Quality System updates for project reviews.

Ensure effective escalation and resolution of quality project risks and delays

Project Risk Management & Compliance Identify and proactively manage risks related to compliance and quality system performance

Ensure QS elements meet regulatory requirements (FDA, ISO 13485, GMP, etc.)Maintain alignment with Global processes and initiatives

Minimum Requirements Minimum of a bachelor’s degree in engineering or science, or equivalent experience

Minimum of seven years of experience in medical device, pharmaceutical, or regulated industry.

Good ability to drive continuous improvement, correct deficiencies and to prevent recurrence

Strong knowledge of Quality Management Systems (QMS), FDA regulations (21 CFR Part 820 / 21 CFR Part 11), and ISO 13485 and applicable global standards

Required Knowledge,

Skills…