Lead Quality Analyst

Hackensack Meridian Health•Houston, TX

11d•Onsite

About The Position

The Lead Quality Analyst ensures the effective implementation of Quality Assurance processes at both local and global levels. This role involves aligning these processes with relevant procedures, standards, and regulations to consistently achieve and maintain high levels of quality and reliability in our products and services.

Requirements

Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 7 years of relevant experience)
Minimum 3 years of professional level experience in a manufacturing environment, with a focus on quality management.
In-depth conceptual and practical knowledge in own job discipline and basic knowledge of related job disciplines.
Knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.
Ability to explain difficult or sensitive information; works to build consensus.

Nice To Haves

5+ years of professional-level experience in a manufacturing environment, with a focus on quality management.
Strong knowledge of quality management systems and standards, including API Specification Q1 and ISO 9001.
Demonstrated ability to manage multiple priorities and meet deadlines.
Strong knowledge of applicable regulatory requirements, procedures, and compliance processes.
Proven ability to organize, motivate, and lead cross-functional teams.
Project management certification (e.g., PMP, Agile) preferred.
Experience in root cause analysis (RCA), process improvement, and nonconformance management.
Six Sigma Green Belt, Lean Manufacturing, or equivalent professional qualification.
High proficiency in Microsoft Excel; familiarity with Power BI is a plus.
Lead Auditor certification in ISO 9001, or deep experience with API Q1/ISO 9001 audits.
Familiarity with system integration (e.g., SAP, Windchill, Infobay) is desirable.
Ability to present complex, data-driven topics clearly, concisely, and persuasively.
Demonstrated leadership, integrity, accountability, and a passion for operational excellence.
Commitment to fostering a positive, inclusive, and collaborative work environment.
Action-oriented mindset—promoting standardization, simplification, and proactive continuous improvement

Responsibilities

Act as the local ambassador and agent within the NAM region and at the JFK facility for global quality programs, processes, tools, and strategy, ensuring organizational compliance and commitment.
Drive nonconformance reports through the process to ensure production defects are addressed properly and in a timely manner.
Provide dispositions for nonconformances related to quality, traceability, documentation, expired material, and cosmetic defects on products from inventory.
Evaluate process/product conformance, provide/evaluate product history for O&R, and perform quality audits for various manufacturing/business processes.
Support manufacturing/supplier cost of poor quality (CoPQ) and identify/implement solutions to reduce impact on the business.
Serve as Quality representative for manufacturing day-to-day operations, sales order creation, and service engineering dispositions.
Assign Cost Centers for scrap and rework activities to drive accurate financial accounting of discrepancies.
Drive corrective actions/preventive actions (CAPAs) to prevent manufacturing/supplier defects.
Support the continuous improvement process and drive participation/engagement in Quality Thursdays and Gemba Walks.
Calculate first pass yield (FPY), analyze data, and develop plans to address high defect areas.
Act as a point of contact and key manufacturing resource for internal/external audits.
Serve as an internal auditor for HMH Internal Audit program based on OS procedures, API, and ISO requirements.
Deliver comprehensive training programs on QMS procedures and business applications (ERP, PLM, etc.).
Work cross-functionally to solve business critical issues, as they arise.
Ensure the timely resolution and closure of audit findings for items registered at the JFK facility and NAM region locations.
Analyze business processes to identify areas for ERP optimization and provide ongoing support for ERP users as needed.
Approve SAP Access Requests and confirm access granted to business users on a quarterly basis as needed.
Specify ERP Inspection Plans for new part numbers delivered to facility, as needed.
Perform additional relevant duties as assigned.
Promote personal accountability for Health, Safety, Security, and Environment (HSSE) by adhering to the principles and guidelines outlined in HMH's HSSE governing policy