Senior Manufacturing Quality Assurance SpecialistJob OverviewThe Senior Manufacturing Quality Assurance Specialist is responsible for providing technical leadership and expertise for quality-related initiatives within manufacturing operations. This role serves as a senior individual contributor and key driver of quality, process improvement, and operational excellence, working across functions to improve product and process performance and embed a strong culture of quality throughout the organization.
The Senior Manufacturing Quality Assurance Specialist leads complex quality investigations and improvement initiatives, applies advanced quality engineering methods to manufacturing challenges, and provides technical guidance to cross-functional teams. The role works closely with Manufacturing, Engineering, Supply Chain, and other stakeholders to develop, implement, and sustain quality systems, processes, procedures, and controls that improve performance, ensure compliance, reduce risk, and lower the cost of quality.
The successful candidate will combine strong technical quality expertise with the ability to influence, facilitate, and lead initiatives across the organization without relying on direct authority.
Duties and ResponsibilitiesQuality Leadership & Continuous Improvement- Provide senior-level quality engineering expertise and technical leadership in support of manufacturing operations, product quality, and continuous improvement.
- Lead and facilitate complex quality improvement initiatives using structured problem-solving and data-driven methodologies to improve manufacturing performance and quality outcomes.
- Support the ongoing development and improvement of the Quality Management System (QMS), ensuring alignment with internal requirements, industry standards, and applicable regulatory requirements.
- Plan, conduct, and support quality and process audits, identify systemic gaps, and drive effective corrective actions and follow-through.
- Lead complex Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) activities, ensuring root causes are supported by evidence and corrective actions are effective and sustainable.
- Perform management system and process analysis to identify systemic inefficiencies, risks, recurring issues, and opportunities for improvement across the QMS and manufacturing environment.
- Develop, implement, and improve process controls and quality assurance methods to improve product consistency, process capability, and manufacturing performance while reducing variation.
- Apply quality engineering tools and methodologies to analyze manufacturing processes, identify failure modes and sources of variation, and recommend technically sound solutions.
- Provide technical guidance and mentorship to engineers, manufacturing personnel, inspectors, and other stakeholders on quality tools, methodologies, and structured problem-solving.
- Analyze cost of quality, including internal and external failure costs, and identify and lead initiatives that reduce quality-related costs and operational waste.
- Conduct and support quality reviews of manufacturing processes, materials, components, and finished products to identify risks and opportunities for improvement.
- Leverage quality data, statistical analysis, and performance metrics to identify trends, prioritize improvement opportunities, and support fact-based decision-making.
- Define and monitor quality and process performance metrics, identifying emerging issues and initiating appropriate corrective or improvement activities.
- Support the development, review, and maintenance of standard operating procedures (SOPs), work instructions, inspection criteria, quality plans, and other controlled documentation.
- Support effective document control practices to ensure quality documentation remains accurate, current, accessible, and compliant with QMS requirements.
- Partner with cross-functional teams on new product introductions, manufacturing changes, process improvements, and product quality issues, ensuring quality requirements and risks are appropriately addressed.
- Serve as a subject matter expert for quality engineering, promoting best practices and helping strengthen quality capability across the organization.
- Champion a culture of continuous improvement, prevention, and quality at the source, influencing stakeholders at all levels to improve quality outcomes.
Required Knowledge, Skills & Experience- Bachelor's degree in Quality Engineering, Industrial Engineering, Mechanical Engineering, Electrical Engineering, or a related technical discipline.
- 5+ years of progressive quality engineering experience in a manufacturing environment, including demonstrated experience independently leading complex quality initiatives and investigations.
- Strong technical knowledge of quality engineering principles, manufacturing processes, process controls, and continuous improvement methodologies.
- Demonstrated expertise in Root Cause Analysis (RCA), CAPA, structured problem-solving, and process auditing.
- Working knowledge of international quality management standards, including ISO 9001, and experience applying QMS requirements within a manufacturing environment.
- Demonstrated ability to lead and deliver cross-functional quality and process improvement projects from problem definition through implementation and verification of effectiveness.
- Advanced proficiency with quality tools and methodologies such as:
- 8D
- 5 Why
- Ishikawa/Fishbone
- Pareto Analysis
- Control Charts/SPC
- Process Capability Analysis
- Measurement Systems Analysis (MSA)
- Failure Modes and Effects Analysis (FMEA)
- Risk-Based Analysis
- Strong analytical skills with the ability to interpret manufacturing and quality data, identify trends, distinguish symptoms from systemic causes, and translate analysis into effective actions.
- Strong understanding of statistical methods and data-driven decision-making as applied to manufacturing and quality engineering.
- Demonstrated ability to operate as a technical leader and subject matter expert, influencing decisions and driving action without direct reporting authority.
- Excellent written and verbal communication skills, with the ability to clearly communicate complex quality and technical issues to both technical and non-technical audiences.
- Strong facilitation skills and demonstrated ability to lead cross-functional problem-solving activities and build alignment among diverse stakeholders.
- Detail-oriented with a strong commitment to product quality, process discipline, and sustainable solutions.
- Results-driven and proactive, with the ability to independently manage multiple priorities, investigations, and improvement initiatives.
- Strong interpersonal and collaboration skills with the ability to build credibility and effective working relationships across Manufacturing, Engineering, Supply Chain, and other functions.
- Demonstrated commitment to continuous improvement, prevention-based quality, and data-driven decision-making.
Preferred Knowledge, Skills & Experience- ASQ Certified Quality Engineer (CQE) or equivalent professional certification.
- Certification or formal training in Six Sigma, Lean Manufacturing, ISO 9001 auditing, or related quality and continuous improvement methodologies.
- Experience with Statistical Process Control (SPC), Design of Experiments (DOE), advanced Measurement Systems Analysis (MSA), process capability analysis, and statistical software.
- Experience supporting New Product Introduction (NPI), design/manufacturing changes, supplier quality, or production readiness activities.
- Experience facilitating FMEA, risk assessments, and Design for Manufacturing (DFM) / Design for Quality (DFQ) reviews.
- Demonstrated experience mentoring or coaching others in quality engineering tools, structured problem-solving, and continuous improvement.
