CAPA Project Engineer II or Sr

4 weeks ago Be among the first 25 applicants

LSI SOLUTIONS® founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We have doubled in size in just the last 4 years! The LSI Campus includes 10 buildings (170,000+ sq ft) on 95 meticulously cared for acres.

We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS® an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state‑of‑the‑art devices. After all, our customer is ultimately the patient.

CAPA Project Engineer (Days 8am to 5pm)

8:00am to 5:00pm.

Onsite at LSI Solutions in Victor, NY.

$77,000 to $110,000

The CAPA Project Engineer combines elements of process and project engineering. Leads the corrective and preventive action (CAPA) process to ensure accurate root causes are determined, appropriate solution plans identified, and necessary product and process improvements are followed through effectively. This includes driving and motivating others to take action by engaging resources and leading small cross‑functional teams, and interfacing with management and peers to report progress and assess and improve the CAPA process.

• Directly facilitate and/or execute CAPA projects, including but not limited to problem statement development, root cause investigation, corrective action development, and implementation with minimal mentoring.
• Plan and lead routine CAPA review meetings.
• Maintain, monitor, and present metrics about the CAPA system to management.
• Employ specialized root cause identification techniques in the successful resolution of CAPAs (e.g. Fault Tree Analysis, Convergent Problem Solving, etc.).
• Develop, write, and revise Quality Management System (QMS) documentation, ensuring that process linkages are correctly documented throughout the QMS.
• Assist in the identification and implementation of improvements to the CAPA System.

• Directly facilitate and/or execute CAPA projects, including but not limited to problem statement development, root cause investigation, corrective action development, and implementation with no mentoring and also provides mentoring in the aforementioned areas.
• Mentor more junior CAPA Engineers in CAPA process and guide the execution of CAPAs.
• Lead the identification and implementation of continuous improvement efforts of the CAPA process.
• Continuously develop and review metrics to provide management insight into CAPA program health.

• Provide support for projects as needed.
• Provide support for internal and external audits and inspections as needed.
• All other duties as assigned.

• Bachelor’s degree in Engineering or relevant technical field.
• 4-7 years of relevant work experience, or Master’s degree with 3+ years of experience.
• Experience applying lean manufacturing principles and Six Sigma methodologies required.
• Demonstrated experience successfully leading problem‑solving efforts required, CAPA system experience preferred.
• Experience in a regulated industry (e.g. Medical Device or Pharma) preferred.

• Bachelor’s degree in Engineering or relevant technical field.
• 7+ years of relevant work experience, or Master’s degree with 6+ years of experience.
• Experience successfully applying lean manufacturing principles and Six Sigma methodologies required. Certification in Six Sigma preferred.
• Demonstrated experience successfully leading problem‑solving efforts required, CAPA system experience required.
• Experience in a regulated industry (e.g. Medical Device or Pharma) required.
• Experience successfully mentoring less experienced engineers.

Completion of a relevant degree not listed above may be considered with additional applicable experience.

• Proficient with MS Office (Outlook, Word, Excel, PowerPoint).
• Mechanical…