Principal Functional Lead, Quality Programs

Job Overview

This role is responsible for leading quality-related initiatives, including Corrective and Preventive Actions (CAPAs), Regulatory Audits, and Management System Plans (MSPs). The position plays an important role in enabling regulatory readiness and serves as the Backroom Manager during audits and inspections.

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.
• 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.
• 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.

Preferred Qualifications

• Demonstrated experience managing Quality Systems elements (CAPA, audits, regulatory inspections, and compliance initiatives).
• Proven ability to drive complex projects and continuous improvement, correct deficiencies and to prevent recurrence to closure.
• Excellent attention to detail, communication, problem-solving, analytical, and organizational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficient computer skills required; expert knowledge of Microsoft Office (including Word, PowerPoint and Excel) required, experience with Enterprise Resource Planning (ERP) system (such as SAP) required.
• Certified Quality Auditor (CQA), Six Sigma, or similar certification.
• Experience serving as an audit backroom lead.

About Us

Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Equal Opportunity Employer

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.