Senior Quality Engineer - Medical Devices & QMS Lead

ARCH; Kenosha (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

ARCH, located in Kenosha, WI, is seeking an experienced Quality Engineer to drive QMS compliance and continuous improvement within a medical device manufacturing setting. You will lead quality initiatives, manage CAPA, and collaborate across departments to sustain product quality from design through production.

The role requires strong knowledge of ISO 13485, FDA 21 CFR 820, and GD&T, plus hands-on experience with PPAP, IQ/OQ/PQ, and supplier quality.

Qualifications

• Bachelor’s degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or related field preferred or equivalent experience.
• Five to seven years of experience in the medical device manufacturing industry and in quality engineering roles.
• Knowledge of ISO 13485 and FDA 21 CFR 820 regulations.
• Geometric Dimensioning and Tolerancing per ASME Y14.5M.
• Familiarity with testing methods for design verification and validation of medical devices.

Responsibilities

• Lead quality control programs to ensure production meets FDA/ISO standards.
• Investigate and address customer complaints (CAPA).
• Assist with internal/external audits of the QMS for compliance.
• Review documents and support reviews of contracts, requirements, and blueprints.
• Create and maintain PPAP documentation (GR&R, control plans, first article inspection).
• Direct inspection and testing activities to maintain process control.
• Train staff on quality standards across departments.
• Collaborate with suppliers to ensure component quality and continuous improvement.

Skills

Self-starter

Leadership

Team collaboration

Quality control programs

CAPA management

Audits and QMS

Document control

Process improvement

Inspection & testing

PPAP

IQ/OQ/PQ

GD&T knowledge

Supplier quality

Education

Bachelor’s degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or related field (preferred or equivalent)

5–7 years in medical device manufacturing quality engineering

Knowledge of ISO 13485 and FDA 21 CFR 820

Tools

CNC machining

GD&T (ASME Y14.5M)

EPICOR ERP

Inspection equipment

Job description

ARCH, located in Kenosha, WI, is seeking an experienced Quality Engineer to drive QMS compliance and continuous improvement within a medical device manufacturing setting. You will lead quality initiatives, manage CAPA, and collaborate across departments to sustain product quality from design through production.

The role requires strong knowledge of ISO 13485, FDA 21 CFR 820, and GD&T, plus hands-on experience with PPAP, IQ/OQ/PQ, and supplier quality.