Senior Quality Engineer — Med Device Quality & Compliance

Cirtec Services GmbH; Santa Clara (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Cirtec Medical Corporation is seeking a Senior Quality Engineer to develop and maintain quality engineering methodologies aligned with customer and regulatory requirements. You will support new product development, operations, and quality systems while acting as a quality representative to drive improvements.

The role emphasizes CAPA ownership, V&V activities, and collaboration with engineering and manufacturing teams, with a pay range of $120,000–$150,000 per year and on-site work in Santa

Qualifications

• Bachelor's degree in a STEM engineering discipline.
• 5 years of engineering experience with mechanical, tool design and manufacturing processes (medical device preferred).
• Proficient in data analysis and Microsoft Office tools.
• Excellent verbal communication, organizational and management skills.
• Minitab experience desirable.

Responsibilities

• Provide Quality Engineering support for engineering product development or manufacturing.
• Provide Quality Project Management support for product transfers from development to production.
• Verification/Validation System Owner for V&V master plan and determinations.
• Develop and maintain SOPs and project Quality Plans.
• Develop protocols, perform analyses, and write reports for validations and development.
• Support IQ/OQ protocols to ensure quality system compliance.
• Provide Quality Engineering support for engineering/manufacturing.
• CAPA system owner or support for corrective actions.
• Interact with customers and suppliers to resolve CAPA and investigations.
• Provide quality disposition for material via NCRs.
• Support supplier quality activities including vendor approval and performance data.
• Review and document procedure changes for quality requirements.
• Develop and maintain production quality control plans.
• Initiate and maintain SPC for production processes.
• Lead or support FMEA and DOE as applicable.
• May serve as backup to Quality Manager.

Skills

Quality engineering

Statistical analysis

Verbal communication

Education

Bachelor's degree in STEM engineering

Tools

Minitab

Excel

PowerPoint

Access

Word

Job description

Cirtec Medical Corporation is seeking a Senior Quality Engineer to develop and maintain quality engineering methodologies aligned with customer and regulatory requirements. You will support new product development, operations, and quality systems while acting as a quality representative to drive improvements.

The role emphasizes CAPA ownership, V&V activities, and collaboration with engineering and manufacturing teams, with a pay range of $120,000–$150,000 per year and on-site work in Santa