Manager, Quality Systems

About Us

With a firm belief that every person and community should have access to the best possible care, 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.

About the Role

This role is responsible for leading quality-related initiatives, including MQRB and Regulatory Audits, and 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 with key quality deliverables. This role manages timelines for QS initiatives, including audit programs, responses, QMS compliance efforts, and system-level improvements to ensure adherence to FDA and global regulatory standards. You will manage QMS elements while supporting the implementation and deployment of Quality Process enhancements. In this role, you will develop and deliver on quality requirements, solve problems, influence a quality-minded culture, and execute objectives for self and others to effect short-term and long-term business goals. Contribute to continuous improvement initiatives to enhance quality project delivery and operational effectiveness.

Responsibilities

• 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.

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.
• Strong ability to drive continuous improvement, correct deficiencies, and 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.

Skills

• Demonstrated experience managing Quality Systems elements (audits, regulatory inspections, and compliance initiatives).
• Strong understanding of audit processes and regulatory inspections.
• Proven ability to drive complex projects and continuous improvement, correct deficiencies, and 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; expert knowledge of Microsoft Office (including Word, PowerPoint, and Excel) required; experience with Enterprise Resource Planning (ERP) system (such as SAP) required.

Preferred Qualifications

• Certified Quality Auditor (CQA), Six Sigma, or similar certification.
• Experience serving as an audit backroom lead.

Supervision

Responsible for the development and management of a small team of engineering/quality professionals.

Internal and External Contacts

All levels internally and externally.

Pay

Annual salary of $115K to $140K depending on experience plus 15% STIP.

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.