Senior Quality Engineer

The Senior Quality Engineer will provide quality engineering leadership and technical support within a regulated medical device manufacturing environment, with a strong focus on manufacturing quality, New Product Introduction (NPI), process validation, compliance, and continuous improvement. This role will partner closely with Operations, Engineering, Manufacturing, and Regulatory teams to ensure products and processes meet customer, quality, and regulatory requirements.

Key Responsibilities

• Lead quality engineering activities supporting manufacturing, NPI, product development, qualification, and validation.
• Develop and implement process controls, inspection plans, control plans, PFMEAs, risk analyses, and other quality documentation.
• Support process validation and equipment qualification activities, including IQ/OQ/PQ and metrology/TMV.
• Analyze process and quality data, including Cpk/Ppk, capability studies, FAI, and visual inspection results; use statistical tools such as Minitab.
• Lead root cause investigations, failure analysis, CAPA, customer complaints, and corrective actions.
• Drive continuous improvement using Lean, Six Sigma, DMAIC, and other structured problem-solving methodologies.
• Conduct internal and customer audits, develop corrective actions, and support timely closure of audit findings.
• Ensure manufacturing processes and quality systems comply with FDA, ISO 13485, MDD/MDR, and applicable customer and global regulatory requirements.
• Serve as a quality and regulatory SME on cross‑functional project teams and provide technical guidance to Quality Engineers and Inspectors.
• Partner with customers and internal stakeholders to resolve quality issues and deliver NPI and manufacturing objectives.
• Lead or participate in company‑wide quality and operational excellence initiatives.
• Maintain accurate quality records, regulatory documentation, and business/quality systems.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical field.
• 8+ years of experience in quality engineering within medical device, machining, or regulated manufacturing environments.
• Strong knowledge of quality systems, FDA regulations, ISO 13485, MDD/MDR, and applicable industry standards.
• Hands‑on experience with process validation, equipment qualification, FMEA, CAPA, root cause analysis, and risk management.
• Strong statistical analysis and process capability experience; Minitab preferred.
• Advanced blueprint reading and GD&T knowledge preferred.
• Experience with Lean, Six Sigma, DMAIC, or other continuous improvement methodologies.
• Experience with ERP and quality management systems.
• Strong project management, leadership, communication, and problem‑solving skills.
• Ability to work effectively in a fast‑paced manufacturing environment and manage multiple priorities.
• CQE or equivalent quality certification preferred.