Senior Quality Engineer (Manufacturing)

Katalyst Healthcares & Life Sciences; Plano (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in healthcare and life sciences is seeking a Senior Quality Engineer for their manufacturing facility in Plano, TX. The successful candidate will lead quality initiatives, ensure compliance with ISO standards, and manage a team of quality engineers. This role demands strong experience in quality management systems, problem-solving capabilities, and a proactive approach to continuous improvement in quality processes. Eligible candidates should possess a Bachelor's degree in engineering and extensive experience in the field.

Qualifications

• 5+ years of experience in quality engineering, preferably in a manufacturing environment.
• Familiarity with ISO 9001: 2015, SPC, CAPA, FMEA.
• Excellent analytical, organizational, and communication skills.

Responsibilities

• Lead and maintain the organization's ISO 9001: 2015 QMS.
• Implement Statistical Process Control across manufacturing operations.
• Manage the CAPA process, including root cause analysis.

Skills

Problem-solving

Regulatory compliance

Statistical methods

Supplier quality management

Lean principles

Six Sigma tools

Education

Bachelor's degree in engineering or related field

Advanced degree

Job description

• 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.

Responsibilities :

• 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.

Requirements :

• 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.

Create a job alert for this search

Manufacturing Quality Engineer • Plano, TX