Quality Engineer – Finished Goods (Medical Devices)

Lsi Solutions Inc; Town of Victor (NY); On-site; USD 67,000 - 114,000; Full time

Benefits offered by this job

Bonus plan

401(k) with company match

Tuition assistance

Employee Assistance Program (EAP)

Product discounts

Paid holidays

PTO & Sick time

Medical/Dental/Vision

Job summary

LSI Solutions Inc is seeking a Quality Engineer to perform quality engineering tasks for new and existing products and processes. The role focuses on finished goods quality engineering and collaboration with internal and external customers and suppliers.

Positions include Engineer I, II, and Senior levels, onsite in Victor, NY, with strong focus on QMS, CAPA, and continuous improvement. Candidates should have technical degrees and relevant experience in a regulated medical device environment.

Qualifications

• Bachelor’s degree or higher in a technical discipline.
• 0-3 years of relevant Engineering experience for entry level; more for senior levels.
• 7+ years of relevant Quality experience for Senior level; Master’s degree can offset required experience.

Responsibilities

• Support development and improvement of QMS processes.
• Dispositon of non-conforming product and CAPA investigations.
• Lead or participate in internal/external audits and inspections.
• Review/approve verification and validation protocols and reports.
• Mentor other Quality Engineers as needed.

Skills

ISO 13485

Problem solving

Communication

MS Office

Education

Bachelor’s degree in a technical discipline

Master’s degree in a technical discipline

Tools

SPC

DOE

Gage R&R

PCP

Job description

LSI Solutions Inc is seeking a Quality Engineer to perform quality engineering tasks for new and existing products and processes. The role focuses on finished goods quality engineering and collaboration with internal and external customers and suppliers.

Positions include Engineer I, II, and Senior levels, onsite in Victor, NY, with strong focus on QMS, CAPA, and continuous improvement. Candidates should have technical degrees and relevant experience in a regulated medical device environment.