Quality Engineer - Medical Devices | IATF 16949 & CAPA

Actalent; Vicksburg (MI); On-site; USD 46,000 - 56,000; Full time

Job summary

Actalent is seeking a Quality Engineer for a contract-to-hire role in Vicksburg, MI. You will interpret engineering drawings with GD&T expertise, support medical product validation, and ensure compliance with IATF 16949 and ISO 9001 standards.

The position emphasizes quality system development and cross-functional collaboration. Responsibilities include CAPA, PPAP, PFMEAs, and audits, with scale calibration and data analysis for continuous improvement.

Qualifications

• Interpreting and reviewing GD&T, ensuring design and process conformance.
• Experience with IATF 16949, ISO 9001, and medical device quality requirements.
• Developing and maintaining quality systems, PPAP, and SPC processes.

Responsibilities

• Perform first article inspections and compare results to specs.
• Lead CAPA using 8D, 5 Why, and Fishbone methodologies.
• Support internal and supplier audits and regulatory reviews.

Skills

quality systems

IATF 16949

quality engineer

management

GD&T

GRR

PPAP

SPC

continuous improvement

Tools

Minitab

Job description

Actalent is seeking a Quality Engineer for a contract-to-hire role in Vicksburg, MI. You will interpret engineering drawings with GD&T expertise, support medical product validation, and ensure compliance with IATF 16949 and ISO 9001 standards.

The position emphasizes quality system development and cross-functional collaboration. Responsibilities include CAPA, PPAP, PFMEAs, and audits, with scale calibration and data analysis for continuous improvement.