Job Scope:
• Lead the engineering and quality activities that guarantee robust, repeatable manufacturing processes. Own process design, control, validation, and improvement to meet product specifications, reduce defects, and ensure compliance.
Primary Responsibilities:
• Lead a team of quality and process engineers; set objectives, coach, and manage performance.
• Design and maintain process controls, work instructions, SOPs, and engineering standards.
• Drive engineering solutions to improve product quality, yield, and manufacturability.
• Lead root-cause analysis and corrective actions (8D/DMAIC); verify effectiveness of fixes.
• Plan and execute process validations, qualifications, and change-control with engineering rigor.
• Use statistical methods (SPC, DOE, MSA) to measure process capability and reduce variation.
• Define, track and report core quality and engineering KPIs (Cp/Cpk, yield, DPMO, scrap, first-pass yield).
• Collaborate with R&D, manufacturing, suppliers and supply chain to ensure quality by design.
• Manage supplier process quality and technical audits for critical vendors.
• Support internal and external audits and ensure documentation meets regulatory and quality system requirements.
Qualifications:
• Bachelor’s degree in engineering (Mechanical, Electrical, Industrial, Chemical) or related field;
• 8+ years of experience in process and quality engineering within manufacturing; prior leadership/people management experience.
• Strong foundation in statistics and quality tools (SPC, DOE, MSA), and process capability analysis (Cp/Cpk).
• Proven experience with RCA and corrective actions (8D, DMAIC) and CAPA processes.
• Experience with process validation/qualification (IQ/OQ/PQ) and change control.
• Supplier quality management and technical auditing experience.
Personal Skills:
• Quality mindset with a disciplined approach to process design and validation
• Strong analytical and data-driven decision making
• Effective coaching and performance management
• Stakeholder management and cross-functional collaboration
• Change management and risk assessment
