Quality Manager: ISO/FDA Compliance & Process Improvement

Actalent; Milwaukee (WI); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

401(k) plan

Health, dental, vision benefits

Job summary

Actalent is seeking a Quality Manager in Milwaukee, WI to lead quality initiatives across manufacturing, engineering, and admin functions. You will ensure compliance with ISO 9001, ISO 13485, FDA, and other standards while guiding a team of quality technicians to uphold customer specifications.

The role involves coordinating audits, managing PPAP and CAPA processes, and driving continuous improvement through Six Sigma methodologies and robust metrology practices.

Qualifications

• Root cause analysis and problem-solving skills for quality improvements.
• Knowledge of ISO 9001, ISO 13485, FDA and related standards.
• Experience leading manufacturing teams or quality functions.
• Proficiency with metrology equipment (CMM, Romer Arm, Microview) and gages.

Responsibilities

• Prioritize, schedule, and delegate work while supervising quality technicians to meet specs and standards.
• Communicate with customers about issues, requests, and new product introductions.
• Host customer and regulatory audits.
• Manage PPAP, CAPA, internal audits, and KPI tracking per ISO 9001.

Skills

Root cause analysis

Quality management

Metal fabrication

PPAP APQP

Quality audit

ISO standards

Experience in manufacturing leadership

Coordinate measuring equipment

Calipers, micrometers, thread gages

Tools

CMM

Romer Arm

Microview

Job description

Actalent is seeking a Quality Manager in Milwaukee, WI to lead quality initiatives across manufacturing, engineering, and admin functions. You will ensure compliance with ISO 9001, ISO 13485, FDA, and other standards while guiding a team of quality technicians to uphold customer specifications.

The role involves coordinating audits, managing PPAP and CAPA processes, and driving continuous improvement through Six Sigma methodologies and robust metrology practices.