Sr Quality Analyst

Job Description

Job Description

Department: Quality

Reports To: Quality Manager

Employment Type: Full-time

Work Location: Onsite – Farmington Hills, Michigan

Job Summary:

The Senior Quality Analyst is responsible for supporting and enhancing the organization’s quality assurance processes by performing advanced quality analysis, identifying risks, and ensuring compliance with internal standards and external regulatory requirements. The role requires a strong focus on data-driven decision-making, root cause analysis, and continuous improvement.

Key Responsibilities:

• Develop and execute quality plans, protocols, and procedures to evaluate processes, products, and systems.
• Conduct inspections, audits, and testing to ensure compliance with quality standards and specifications.
• Review and approve quality documentation such as inspection reports, deviation reports, and change requests.
• Analyze quality data (e.g., non-conformances, defect trends, process capability) to identify issues and improvement opportunities.
• Prepare regular quality reports and dashboards for management review.
• Support risk analysis activities such as FMEA (Failure Mode and Effects Analysis).
• Lead or support root cause analysis and implement corrective/preventive actions (CAPA).
• Identify and propose quality improvement initiatives based on findings.
• Participate in Lean/Six Sigma or other continuous improvement projects.
• Ensure adherence to regulatory and industry standards (e.g., ISO, FDA, GMP, depending on the industry).
• Support internal and external audits by preparing documentation and participating in audit activities.
• Monitor and report on compliance with quality policies and procedures.
• Provide guidance and training to junior quality analysts and other team members on quality tools and techniques.
• Collaborate with cross-functional teams to ensure quality is integrated into all phases of the product lifecycle or operational workflow.

Qualifications:

• Bachelor’s degree in Quality, Engineering, Science, Information Systems, or a related field.
• 5+ years of experience in a quality assurance or quality control role, with at least 2 years in a senior or lead capacity.
• Strong understanding of quality systems, statistical process control, and root cause analysis tools.
• Familiarity with industry-specific standards (e.g., ISO 9001, ISO 13485, IATF 16949, FDA, or equivalent).
• Experience using quality tools (e.g., Pareto analysis, control charts, fishbone diagrams) and quality software systems (e.g., QMS, LIMS, issue tracking systems).
• Excellent analytical, problem-solving, and communication skills.
• Quality certifications (e.g., ASQ Certified Quality Analyst, Six Sigma Green Belt) are preferred.

Physical Requirements:

• Prolonged sitting for extended periods of time.
• Frequently use of hands and fingers for typing, mouse operation, and other computer-related tasks.

About LSPedia
Welcome to LSPedia, a global software (SaaS) leader at the forefront of traceability, compliance, and supply chain solutions, dedicated to empowering the pharmaceutical, healthcare, and food industries. As a distinguished Top 50 Michigan Company and recognized on INC's list of the fastest-growing companies in America, LSPedia stands as a beacon of innovation and excellence.

Our cutting-edge software solutions have earned the trust of major players in the pharmaceutical and healthcare sectors, including esteemed organizations such as the U.S. Department of Veterans Affairs, Cencora, Cardinal Health, Leading Pharma, Tris Pharma, Amazon, Ascension Health, and thousands more. We take pride in our commitment to delivering unparalleled traceability and compliance solutions that redefine industry standards.

At LSPedia, we are fueled by a passion for innovation and a commitment to excellence. Join our rockstar team as we continue to expand and shape the future of traceability and supply chain solutions. We are actively seeking individuals who share our vision and enthusiasm to contribute to the ongoing success of our dynamic and growing company. Together, we are driving the evolution of industries and shaping a more connected, compliant, and efficient future.