What are the responsibilities and job description for the Lead Quality Engineer position at Katalyst Healthcares & Life Sciences?
Job Description:
We are seeking an experienced Lead Quality Enginee r to drive quality initiatives throughout the product lifecycle. This role is responsible for leading quality engineering activities, ensuring compliance with regulatory and industry standards, managing risk, supporting new product development, and driving continuous improvement across manufacturing and supplier operations. The ideal candidate will have strong leadership skills and experience in regulated manufacturing environments such as medical devices, pharmaceuticals, automotive, aerospace, or industrial manufacturing.
Responsibilities:
We are seeking an experienced Lead Quality Enginee r to drive quality initiatives throughout the product lifecycle. This role is responsible for leading quality engineering activities, ensuring compliance with regulatory and industry standards, managing risk, supporting new product development, and driving continuous improvement across manufacturing and supplier operations. The ideal candidate will have strong leadership skills and experience in regulated manufacturing environments such as medical devices, pharmaceuticals, automotive, aerospace, or industrial manufacturing.
Responsibilities:
- Lead Quality Engineering activities for new product development (NPD), manufacturing, and sustaining engineering projects.
- Develop and maintain Quality Management System (QMS) processes in compliance with applicable regulatory requirements.
- Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
- Lead root cause investigations using 8D, 5 Why, Fishbone, and other problem-solving tools.
- Manage CAPA, Non-Conformance (Client), Deviations, and Change Control activities.
- Perform risk assessments using FMEA, Risk Management, and Control Plans.
- Ensure compliance with ISO 9001, ISO 13485, IATF 16949, AS9100, GMP, FDA, or other applicable quality standards.
- Collaborate with Design, Manufacturing, Supplier Quality, Operations, Regulatory Affairs, and Production teams.
- Lead supplier quality improvement activities including supplier audits, qualification, and corrective actions.
- Support design verification, validation, process validation (IQ/OQ/PQ), and equipment qualification.
- Develop inspection plans, sampling plans, quality metrics, dashboards, and KPIs.
- Conduct internal audits and support external regulatory inspections and customer audits.
- Mentor junior quality engineers and provide technical leadership across cross-functional teams.
- Review engineering changes and ensure quality requirements are incorporated.
- Analyze quality data using statistical tools such as SPC, Minitab, Cp/Cpk, and trend analysis.
Requirements:
- Bachelor's degree in Engineering, Quality, Manufacturing, Mechanical, Biomedical, Industrial, Chemical, or a related discipline.
- 7 12 years of Quality Engineering experience in a regulated manufacturing environment.
- 2 5 years of experience leading quality engineering teams or projects.
- Strong knowledge of Quality Management Systems (QMS).
- Experience with CAPA, Client, Root Cause Analysis, FMEA, Control Plans, and Risk Management.
- Hands-on experience with validation protocols (IQ/OQ/PQ) and process qualification.
- Knowledge of statistical analysis and Statistical Process Control (SPC).
- Experience supporting supplier quality and customer quality initiatives.
- Excellent communication, leadership, and project management skills.
Preferred Qualifications:
- Certified Quality Engineer (CQE) certification.
- Six Sigma Green Belt or Black Belt certification.
- Lead Auditor certification.
- Experience with ERP systems such as SAP, Oracle, or JD Edwards.
- Experience using Minitab, JMP, or other statistical software.
- Familiarity with Agile, Stage-Gate, or Product Lifecycle Management (PLM) processes.