Senior Quality Engineer, CAPA; Wayne, NJ

Senior Quality Engineer, CAPA (Wayne, NJ)

Location:

Wayne, NJ, US

Company:
Datascope Corp.

Remote Work: 1-2 days at home (site based)

Salary Range: $115‑130k

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.

The Sr. Quality Engineer supports the Cardiac Assist business and leads and/or provides support for activities to ensure QMS compliance, with an emphasis on the CAPA process. This includes:

• Diving cross‑functional problem‑solving teams to maintain timeliness of CAPA activities and associated documentation.
• Providing guidance to ensure thorough investigation to support root‑cause and action plans to improve product/process.
• Supporting measuring and monitoring of CAPA program as needed.
• Supporting 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.

• Support initiation and assignment of CAPAs as required.
• Guide CAPA Owners to ensure proper CAPA investigation, action planning, implementation, and effectiveness check planning and execution. Ensure the Effectiveness Check addresses the problem statement.
• Drive 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 and highlight any perceived risk that could lead to undue delays.
• Ensure CAPAs are documented in compliance with applicable standards, regulations, and procedural requirements.
• Assist CAPA Owners with the use of the Track Wise electronic CAPA system to ensure that CAPA records remain in a state of audit readiness.
• Measure and monitor the CAPA program.
• Act as 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 QMS in accordance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards and regulations.
• Participate in and/or conduct regular internal audits and manage external audits to ensure compliance with regulatory requirements.
• Develop and monitor key quality metrics to assess 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, and work instructions.
• Monitor and report on status of action items/plans initiated to address external audit findings.
• Assist in preparation of responses to authority/notified body audit findings and communications.

• Bachelor’s Degree in engineering, science, or a related field is required. A Master of Science in Engineering, Science, or related field is preferred.
• Minimum 5 years hands‑on experience with management of CAPAs and CAPA processes.
• 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. Track Wise) is preferred.
• Strong analytical and problem‑solving skills with focus on root cause analysis and corrective actions. Must have ability to autonomously analyze and solve semi‑complex problems.
• Effective communication and interpersonal skills, with ability to work collaboratively across departments.
• Proficiency in quality management software and tools.
• Detail‑oriented with strong organizational skills and ability to manage multiple tasks simultaneously.
• Excellent oral and technical writing skills with ability to interface effectively and professionally across departments and at all reporting levels.
• Working knowledge of quality systems required. Familiarity with analytical software (i.e. Minitab) applications preferred.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, or equivalent) 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%.

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