Senior Quality Engineer

The Opportunity

Cala Health is seeking a Senior Quality Engineer to join our growing team. The Senior Quality Engineer at Cala Health Inc. will support operations by leading quality processes, performing root cause analysis, and collaborating with internal team members and suppliers to improve product quality. They will work closely with the engineering & manufacturing team to support new design projects and identify and lead continuous QMS process improvements. Additionally, the role involves reviewing documentation for design and manufacturing validation, generating risk assessments, and driving continuous improvement through constructive feedback and KPI analysis.

This role is onsite at our San Mateo office. The compensation range for this role is market driven with a salary range of $95,000 - $150,000. Additionally, we offer a robust benefits package. This offer is aligned with our overall compensation philosophy.

Specific Responsibilities

• Responsible for providing quality engineering support for Operations (i.e. Manufacturing, IQA, and Sustaining)
• Lead and support quality processes related to NCMR, CAPA, Risk Assessments, and SCAR’s by performing root cause analysis and solution implementation plan
• Collaborate with Cala’s suppliers in resolving issues and improving quality
• Review documentation for design V&V activity as well as manufacturing process/equipment validation (IQ/OQ/PQ)
• Responsible for generating, updating, and/or reviewing risk documentation (i.e. FMEA’s, risk analysis files, risk assessments)
• Identify and lead continuous QMS process/system improvements
• Work in collaboration with R&D department to support new design projects
• Support complaint investigations for post market surveillance reporting
• Identify KPI’s and generate reports/analysis to review commercial product quality and manufacturing quality for management review
• Drive continuous improvement by offering constructive feedback on existing processes
• Support ongoing training of Quality assurance and GDP
• Ensure compliance with all corporate, regulatory, safety, and production policies and procedures
• Exhibit strong organizational skills and attention to detail
• Work independently as necessary to support quality objectives

Skills and Experience

• BS degree in a related field or equivalent level of experience (4-8 years)
• 8+ years of medical device experience in quality engineering/assurance
• Familiarity with CRM & eQMS system such as SalesForce, Arena, or equivalent
• Extensive working knowledge within a regulated environment (ISO 13485 & FDA)
• Working statistical knowledge for trend analysis
• Extensive working knowledge with MS Office and Excel or Google Docs and Sheets
• Excellent technical verbal/written communication skills
• Process orientation when planning and performing work