The Opportunity

Cala Health is seeking a Quality Engineer II to join our growing team. The Quality Engineer II will support manufacturing and quality operations, drive process improvements, and collaborate with suppliers to ensure exceptional product standards. You'll also contribute to risk assessments, validation activities, and quality system enhancements. Be a part of a fast-paced, mission-driven team making a difference in healthcare.

This role is onsite at our San Mateo office. The compensation range for this role is market driven with a salary range of $90,000 - $125,000. Additionally, we offer a robust benefits package. This offer is aligned with our overall compensation philosophy.

Specific Responsibilities

• Provide quality engineering support for Operations (i.e. Manufacturing, IQA, and Sustaining)
• 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)
• Assist in generating, updating, and/or reviewing risk documentation (i.e. FMEA’s, risk analysis files, risk assessments)
• Track nonconforming material & CAPA and lead Material Review Board (MRB) efforts
• Support continuous QMS process/system improvements
• Support device complaint investigations on returned product
• Support monitoring and evaluation quality system metrics

General Responsibilities

• 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 an attention to detail
• Work independently as necessary to support quality objectives
• Fulfill any other duties as assigned

Skills and Experience

• S. degree in an engineering related field or equivalent level of experience
• A minimum of 3 years of medical device experience in quality engineering/assurance
• Familiarity with eQMS system such as Arena, or equivalent
• Working knowledge within a regulated environment (ISO 13485 & FDA QSR)
• Working statistical knowledge for trend analysis and control techniques
• Understanding of concepts and principles of Quality Assurance with respect to new product development, external suppliers and product manufacturing
• Experience in product and process verifications and validations
• Extensive working knowledge with MS Office and Excel or Google Docs and Sheets
• Excellent technical verbal/written communication skills and ability to work well in small teams
• Process orientation when planning and performing work

Physical Demands

• Able to work in a fast-paced production environment
• Ability to lift and handle objects up to 20 pounds
• While performing the duties of this job, the employee may be regularly required to stand, sit, talk, hear, reach, and use hands and fingers to operate a computer, telephone and keyboard
• Specific vision abilities required by this job include close vision requirements due to computer work
• Ability to sit or stand at a desk for extended periods of time