Sr. Quality Sustaining Engineer

 

 

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

As a Senior Quality Sustaining Engineer, you will play a key role in ensuring that Healthmark products across Getinge’s Infection Control Consumables portfolio meet applicable quality and regulatory requirements. This includes FDA Class I and II medical devices, EU MDR Class I devices, and selected non-regulated products.

 

In this role, you will take ownership of quality engineering activities within the product lifecycle, including design changes, production quality, and post-market support. You will work cross-functionally with Regulatory Affairs, R&D, Manufacturing, and Operations to drive compliant and effective product lifecycle management while independently leading initiatives and contributing to continuous improvement efforts.

 

Job Responsibilities and Essential Duties:

• Lead design change transfer deliverables and activities in accordance with FDA Quality System requirements (21 CFR Part 820 / QMSR), EU MDR (2017/745), and applicable internal quality system procedures
• Take ownership of quality engineering deliverables for assigned products or projects, ensuring compliance with regulatory requirements and internal procedures throughout the product lifecycle
• Ensure critical-to-quality (CTQ) attributes are appropriately defined and implemented, and support the development of acceptance activities, equipment qualification, calibration, validation, and production/process controls
• Provide quality engineering leadership and technical input in the design, fabrication, development, installation, validation, and qualification of equipment and processes, including feasibility assessments and documentation
• Lead root cause investigations and resolution of complex quality issues, including product complaints, nonconformances, and production-related issues, ensuring timely and effective corrective actions
• Serve as a Quality subject-matter expert for PFMEA and risk management activities in accordance with ISO 14971:2019, supporting risk-based decision-making
• Support development, review, and improvement of production process documentation, including work instructions and change control activities
• Support internal and external audits by preparing documentation, providing objective evidence, and participating in audit discussions
• Analyze quality data and trends (e.g., SPC, complaints, nonconformances) to identify improvement opportunities and support data-driven decision-making
• Drive and participate in continuous improvement initiatives to enhance product quality, process efficiency, and compliance
• Act as a key quality representative on cross-functional teams, collaborating with stakeholders to resolve issues and ensure alignment
• Build effective working relationships across functions, leveraging expertise from colleagues to achieve project and quality objectives
• Provide guidance and mentorship to less experienced engineers as needed

 

Required Knowledge, Skills and Abilities:

• Demonstrated leadership in problem-solving and driving quality-related initiatives within cross-functional teams
• Strong decision-making and analytical skills, with the ability to apply risk-based thinking
• Ability to assess the impact of quality decisions on product performance and compliance
• In-depth knowledge of applicable quality and regulatory standards
• Experience with data analysis, trending, and statistical tools
• Effective communication and interpersonal skills, with the ability to collaborate across organizational levels
• Ability to manage multiple priorities in a fast-paced environment

Minimum Requirements: 

• Bachelor’s degree in science, engineering, or other technical areas; or e