Finished Goods Quality Engineer — Medical Devices

Regulatory Jobs; Town of Victor (NY); On-site; USD 67,000 - 114,000; Full time

Benefits offered by this job

Bonus Plan

401(k) plan with company match

Tuition Assistance

Employee Assistance Program (EAP)

Product Discounts

14+ Paid Holidays (example)

Job summary

LSI SOLUTIONS® in Victor, NY is seeking a Quality Engineer-Finished Goods to join a ISO 13485–certified medical device team. You will support product and process development, ensure QMS compliance, and collaborate with suppliers and internal customers.

Responsibilities include CAPA investigations, document control, data analysis, audits, and continuous improvement. Opportunities exist for growth across levels with defined career paths.

Qualifications

• Bachelor’s degree or higher in a technical discipline required.
• 0-3 years of relevant Engineering experience in medical device or other regulated industry preferred.
• Bachelor’s degree or higher in a technical discipline with 3 or more years of relevant experience for Quality Engineer II.
• Bachelor’s degree or higher in a technical discipline with 7 or more years of relevant Quality experience for Senior Quality Engineer.
• Master’s degree in a technical discipline with 5 or more years as a Quality Engineer (Senior track).

Responsibilities

• Assist in developing QMS processes and procedures to ensure regulatory compliance.
• Coordinate and disposition non-conforming product.
• Perform data analysis and monitor metrics reporting.
• Lead and support continuous improvement activities.
• Participate in internal and external audits and inspections.
• Generate and maintain procedures, work instructions, and templates.
• Lead CAPA investigations and verify verification/validation reports.
• Review/approve verification and validation protocols and reports.

Skills

Quality engineering

Problem solving

Analytical thinking

Communication skills

GD&T

R&R

MS Word

Excel

Outlook

Education

Bachelor's degree or higher in a technical discipline

Master's degree in a technical discipline (preferred for Senior)

Tools

MS Word

Excel

Outlook

Job description

LSI SOLUTIONS® in Victor, NY is seeking a Quality Engineer-Finished Goods to join a ISO 13485–certified medical device team. You will support product and process development, ensure QMS compliance, and collaborate with suppliers and internal customers.

Responsibilities include CAPA investigations, document control, data analysis, audits, and continuous improvement. Opportunities exist for growth across levels with defined career paths.