Sr. Quality Engineer - CAPA Compliance

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.

Getinge is a global company that designs and manufactures medical devices and life science equipment. We affect the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are engaged in achieving the Paris Agreement goal of limiting global warming to 1.5C above pre-industrial levels.

We focus on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals to join our team.

We currently have an open position for a Sr. Quality Engineer. This position will work across the Cardiac Assist (CA) business areas of the New Jersey sites. This role leads and/or provides support for activities to ensure QMS Compliance, with an emphasis on the Corrective and Preventive Action (CAPA) process. The ideal candidate will effectively:

• Dive cross-functional problem-solving teams to maintain timeliness of CAPA activities and associated documentation.
• Provide guidance to ensure though Investigation to support Root Cause and Action plans to improve product/process.
• Support measuring and monitoring of CAPA program as needed.
• Support oversight of QMS processes, specifically Management Controls.

Job Responsibilities

CAPA Management:

• Support the initiation and assignment of CAPAs as required.
• Support/ guide CAPA Owners to ensure proper CAPA investigation, action planning, action implementation, and effectiveness check planning and execution. Ensure the Effectiveness Check addresses the problem statement.
• Support CAPA Owners in driving CAPA activities to ensure timely completion throughout all phases of the CAPA process.
• As CAPA Coordinator, support CAPA Owner/ team on navigating the CAPA process. Assisting them to highlight any perceived RISK that could lead to undue delays.
• Support CAPA Owners in ensuring that CAPAs are documented in compliance with applicable standards, regulations, and procedural requirements.
• Support CAPA Owners with the use of the TrackWise electronic CAPA system to ensure that CAPA records remain in a state of audit readiness.
• Support measuring and monitoring of the CAPA program.
• Be the CAPA Process SME at audits and support CAPA Owners in preparation & presentation of their CAPA.
• Lead periodic CAPA Review Board meetings.

QMS Compliance

• Oversee and maintain the Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards and regulations.
• Participate and/or conduct regular internal audits and manage external audits to ensure compliance with regulatory requirements.
• Develop and monitor key quality metrics to assess the performance of the QMS and CAPA processes.
• Generate reports and present findings to senior management, highlighting areas for improvement and success stories.
• Utilize data analysis tools to identify trends and drive decision-making processes.
• Develop, implement, and monitor quality policies and procedures to ensure continuous compliance and improvement.
• Prepare and maintain documentation, including quality manuals, standard operating procedures (SOPs), and work instructions.
• Monitor and report on status of action items/ plans initiated to address External Audit findings (Authority
• Assist in preparation of responses to Authority/ Notified Body audit findings and communications.

Required Knowledge, Skills and Abilities

• Bachelor's degree in engineering, Science, or a related field is required. A Master of Science in Engineering, Science, or related field is preferred.
• 5-8 years hands-on experience with management of CAPAs and CAPA process is required.
• ASQ Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) or an equivalent is preferred.
• Excellent understanding of QMS principles and CAPA methodologies.
• Strong analytical and problem-solving skills with a focus on root cause analysis and corrective actions. Must have the ability to autonomously analyze and solve semi-complex problems.
• Effective communication and interpersonal skills, with the ability to work collaboratively across departments.
• Proficiency in quality management software and tools.
• Detail-oriented with strong organizational skills and the ability to manage multiple tasks simultaneously.
• Ability to influence without authority.
• Excellent oral and technical writing skills with the ability to interface effectively and professionally across departments and at all reporting levels.
• Working knowledge of quality systems is required. Familiarity with analytical software (i.e. Minitab) applications is preferred.
• Experience with electronic CAPA management programs (i.e. TrackWise) is preferred.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, or equivalent) is required.

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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.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.