Senior Quality Analyst/Engineer

Robotics Technologies LLC; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading robotics company based in Madison, Wisconsin, is seeking a Quality Management professional to develop and maintain quality system processes and manage CAPA initiatives. The ideal candidate will facilitate audits, support root cause analyses, and improve quality culture through various initiatives. Strong experience with regulatory compliance and quality systems is essential. Join a diverse team where all employment decisions are made without regard to protected statuses.

Qualifications

• Experience in quality management systems and regulatory compliance.
• Ability to lead quality audits and training programs.
• Strong analytical and problem-solving skills.

Responsibilities

• Develop and maintain quality system processes.
• Manage CAPA initiation and reviews.
• Facilitate Quality Management reviews and Change Management processes.
• Facilitate and lead the site Change Management process.
• Support and lead root cause analyses through cross functional team involvement.
• Lead Good Documentation Practice training and Quality on the Floor coordination and performance.
• Interpret and apply regulatory requirements.
• Coordinate and provide direct support for facility audits by internal and external entities.
• Manage data collection and reporting for product recalls."
• Perform trending of Quality Systems to support FDA and Management reviews.
• Improve quality culture through site initiatives and improve procedures to align with regulatory requirements.
• Review and approval of procedures, protocols, reports, etc."],
• CoT_job_summary_short":"COMPANY NAME: Robotics Technologies LLC\nKEY POINTS: Quality system management, CAPA, audits, regulatory alignment" ,

Skills

Quality management

CAPA management

Regulatory knowledge

Root cause analysis

Education

Bachelor's degree in science or engineering

Tools

Documentation control

Job description

Job Description :

Develop and maintain quality system processes, including metrics reporting and tracking

Manage CAPA initiation, review, surveillance, and reporting

Facilitate the site Quality Management reviews

Facilitate and lead the site Change Management process

Support and lead root cause analyses through cross functional team involvement

Leading Good Documentation Practice training and Quality on the Floor coordination and performance

Interpret and properly apply all applicable regulatory requirements

Coordinate and provide direct support for facility audits by internal and external entities

Manage data collection and reporting when product recalls are required

Perform trending of Quality Systems to support FDA and Management reviews

Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements

Review and approval of procedures, protocols, reports, etc., as required.

Filing and management of documentation when required

Supporting other Quality System Functions

This role may be required to lead personnel (inside and outside) the Quality organization in support of the business need

ROBOTICS TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. ROBOTICS TECHNOLOGIES LLC will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will ROBOTICS TECHNOLOGIES LLC require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract