Medical Device Quality Engineer – CAPA, Risk & ISO 13485

Intellectt Inc; Minnesota; On-site; USD 69,000 - 76,000; Full time

Benefits offered by this job

Health Insurance

401k Retirement

PTO

Job summary

Intellectt Inc. is seeking an experienced Quality Engineer to support medical device manufacturing, design controls, risk management, and quality system compliance in a regulated environment.

The ideal candidate will have hands-on knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971. You will lead NCR investigations, CAPA activities and root-cause analysis, develop DFMEA/PFMEA and risk documentation, support process validation, ECO/ECN, inspection plans, and ensure end-to-end traceability

Qualifications

• Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Quality Engineering, Life Sciences, or a related technical discipline.
• 3–5 years of hands-on Quality Engineering experience within the medical device.
• Working knowledge of FDA medical device regulations (21 CFR Part 820 / QMSR), ISO 13485, and ISO 14971 risk management principles.
• Direct experience handling NCRs, CAPAs, root cause analysis (5-Whys, Fishbone), and non-conforming material disposition.
• Strong familiarity with Process Validation (IQ/OQ/PQ), Design Controls, DHF/DMR maintenance, and Change Control processes.
• Practical knowledge of FMEA (DFMEA/PFMEA), SPC, Gauge R&R, and sampling rationales.

Responsibilities

• Develop, review, and execute Quality Engineering documentation in compliance with FDA 21 CFR Part 820 / QMSR and ISO 13485 standards.
• Lead Non‑Conformance (NCR) investigations, deviation resolution, and Corrective and Preventive Action (CAPA) activities using structured Root Cause Analysis (RCA) methodologies.
• Perform and maintain Design and Process Failure Mode and Effects Analysis (DFMEA / PFMEA), hazard analyses, and risk management documentation per ISO 14971 throughout the product lifecycle.
• Support manufacturing floor quality operations, process validation (IQ/OQ/PQ), test method validation (TMV), and engineering change orders (ECO/ECN).
• Establish and review inspection plans, sampling plans (AQL), receiving/in‑process product specifications, and quality control procedures.
• Ensure end‑to‑end traceability across user needs, design inputs, design outputs, risk controls, and verification/validation testing.

Skills

NCR investigations

CAPA investigations

Root cause analysis

DFMEA PFMEA

ISO 13485 knowledge

21 CFR Part 820 knowledge

ISO 14971 risk management

Process validation IQ OQ PQ

Design controls

DHF DMR maintenance

Change control

SPC

Gage R&R

Sampling rationale

Education

Biomedical Engineering

Mechanical Engineering

Quality Engineering

Life Sciences

Job description

Intellectt Inc. is seeking an experienced Quality Engineer to support medical device manufacturing, design controls, risk management, and quality system compliance in a regulated environment.

The ideal candidate will have hands-on knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971. You will lead NCR investigations, CAPA activities and root-cause analysis, develop DFMEA/PFMEA and risk documentation, support process validation, ECO/ECN, inspection plans, and ensure end-to-end traceability