Senior Quality Engineer, CAPA (Wayne, NJ)

Job Overview

The Sr. Quality Engineer supports the Cardiac Assist business and leads and/or provides support for activities to ensure Quality Management System (QMS) Compliance, with an emphasis on the Corrective and Preventive Action (CAPA) process.

Job Responsibilities and Essential Duties

• 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 measuring and monitoring of the CAPA program.
• 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.
• Maintain status of action items/ plans initiated to address External Audit findings.
• Aid 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.
• A minimum of 5 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.
• Experience with electronic CAPA management programs (i.e. TrackWise) is preferred.
• 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.
• 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.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, or equivalent) is required.

Pay

The base salary for the position is a minimum salary of $115,000 and a maximum of $130,000 plus an annual bonus of 10%

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.