Senior Quality Analyst/Engineer

About the role

This role involves developing and maintaining quality system processes, managing CAPA, facilitating Quality Management reviews, leading Change Management, supporting root cause analyses, coordinating audits, managing data during recalls, trending quality systems, improving quality culture, and reviewing documents.

Responsibilities

• Develop and maintain quality system processes, including metrics reporting and tracking
• Manage CAPA initiation, review, surveillance, and reporting
• Facilitate and lead the site Quality Management reviews
• 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 properly apply all applicable regulatory requirements
• Care for and coordinate 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 approve procedures, protocols, reports, etc., as required

Requirements

The ideal candidate should have a Bachelor's degree in a relevant field and at least 5 years of experience in a similar role. Proficiency in regulatory compliance, strong problem-solving skills, and excellent communication and leadership abilities are essential.

Qualifications

Must be a US Citizen, Green Card holder, or have valid work authorization as specified in the job description.

Skills

Strong knowledge of quality systems, regulatory compliance, and project management skills are required. Proficiency in Microsoft Office and familiarity with industry-standard software tools is beneficial.

Benefits

Competitive hourly rate based on experience, health insurance, retirement plan, paid time off, and professional development opportunities.

Pay

Depending on experience (DOE)

Schedule

10 Months + Extension

Benefits

Health insurance, retirement plan, paid time off, and professional development opportunities.

Employment Type

W-2, 1099, C2C

Equal Opportunity Employer

MACHINE LEARNING 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. MACHINE LEARNING 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 MACHINE LEARNING 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.