Principal Functional Lead, Quality Programs

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

This role is responsible for leading quality‑related initiatives, i.e. MQRB, CAPA 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 CAPAs, 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 Quality System team to develop and maintain timelines and milestones for assigned Quality initiatives by leading and managing the following Quality elements:
• Corrective and Preventive Actions (CAPAs) process – tracking approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness as appropriate.
• CAPA Review Board (CRB) governance
• 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, CAPAs, 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