Job OverviewThe 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.
Job Responsibilities and Essential DutiesCAPA 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.
- 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.
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%
#LI-LG1
