Senior Quality Engineer (Manufacturing)
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Plano, TX 75025
Description:
Position Summary:
- We are seeking a highly skilled and detail-oriented Senior Quality Engineer to lead quality initiatives and ensure compliance with applicable standards in a dynamic manufacturing environment.
- This role requires a deep understanding of quality management systems, continuous improvement methodologies, and team leadership.
- The ideal candidate is a proactive problem-solver with strong experience in regulatory compliance, statistical methods, and supplier quality management.
- Lead and maintain the organization's ISO 9001:2015 Quality Management System (QMS) to ensure consistent compliance and continuous improvement.
- Implement and oversee Statistical Process Control (SPC) across manufacturing operations to monitor and improve product quality.
- Supervise and mentor a team of quality engineers and technicians, providing guidance, training, and performance feedback.
- Manage the Corrective and Preventive Action (CAPA) process, including root cause analysis and implementation of effective solutions.
- Conduct and facilitate Failure Mode and Effects Analysis (FMEA) to identify and mitigate potential risks in design and process stages.
- Develop and maintain quality control plans, inspection criteria, and documentation in alignment with customer and regulatory requirements.
- Oversee supplier quality management, including audits, performance evaluations, and corrective action tracking.
- Perform internal audits to evaluate the effectiveness of the QMS and drive improvements.
- Ensure ongoing compliance with regulatory requirements relevant to manufacturing and industry standards.
- Champion Lean manufacturing principles and support cross-functional continuous improvement initiatives.
- Bachelor's degree in engineering or related field; advanced degree a plus.
- 5+ years of experience in quality engineering, preferably in a manufacturing environment.
- Proven experience with ISO 9001:2015 and regulatory standards.
- Strong knowledge of SPC, CAPA, FMEA, and quality planning methodologies.
- Familiarity with Lean and Six Sigma tools and techniques.
- Demonstrated leadership in managing teams and cross-functional projects.
- Excellent analytical, organizational, and communication skills.
- Certified Quality Engineer (CQE) or similar certification preferred.