Senior Quality Engineer, CAPA (Wayne, NJ)

Getinge•Wayne, NJ

1d•$115,000 - $130,000•Hybrid

About The Position

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. This includes: 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. The position is hybrid with the opportunity to work from home 1-2 days a week, otherwise reporting to the Wayne, NJ headquarters.

Requirements

Bachelor’s Degree in engineering, Science, or a related field is required.
A minimum of 5 years hands-on experience with management of CAPAs and CAPA process is required.
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.
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.
Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, or equivalent) is required.

Nice To Haves

A Master of Science in Engineering, Science, or related field is preferred.
ASQ Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) or an equivalent is preferred.
Experience with electronic CAPA management programs (i.e. TrackWise) is preferred.
Familiarity with analytical software (i.e. Minitab) applications is preferred.

Responsibilities

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.
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.