Quality Systems & Compliance Engineer

About the role

The Quality Systems & Compliance Engineer will be responsible for ensuring that all quality systems and compliance requirements are met within the Milwaukee facility. This includes auditing processes, maintaining documentation, and collaborating with cross-functional teams to ensure regulatory compliance.

Responsibilities

• Auditing current quality systems and identifying areas for improvement
• Maintaining and updating documentation related to quality systems and compliance
• Collaborating with cross-functional teams to ensure regulatory compliance
• Participating in internal audits and providing feedback
• Supporting the implementation of new quality systems and compliance initiatives

Requirements

• Bachelor's degree in a relevant field (e.g., engineering, quality management)
• Minimum of 5 years of experience in a quality assurance or compliance role
• Experience with FDA regulations and Good Manufacturing Practices (GMP)
• Strong knowledge of quality system standards such as ISO 13485 and ISO 9001
• Excellent communication and interpersonal skills
• Proficiency in Microsoft Office Suite

Qualifications

• Ability to work independently and as part of a team
• Strong problem-solving and analytical skills
• Experience with quality management software (e.g., SAP, QMS)
• Knowledge of GxP data management systems

Skills

• Quality systems and compliance expertise
• Regulatory compliance and audit readiness
• Documentation and record-keeping proficiency
• Team collaboration and leadership

Benefits

• Competitive compensation package including health insurance, retirement plan, and paid time off
• Flexible work schedule to accommodate personal and professional needs
• Professional development opportunities and training programs

Pay

75 - 90 USD Annually

Schedule

Full-time position