Santa Clara, CA30+ days ago
RESPONSIBILITIES:Lead and/or support on-time completion of Design Control deliverablesSupport the establishment of objective, measurable, and verifiable product requirementsSupport Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activitiesLead Risk Management activities from product concept through commercializationSupport test method development and lead test method validation activitiesSupport manufacturing process development & qualification for new product and design changesSupport the establishment of component specification definitions, supplied component sampling plan development, and vendor qualificationsSupport biocompatibility and sterilization qualificationsSupport audits and quality system improvement activitiesSupport Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements. Key ResponsibilitiesSupport Quality for software development, manufacturing, operations, and engineering teamsReview/approve SDLC documentsLead Hazard Analysis activitiesAssist with SOPs, Work Instructions, and occasional trainingOccasionally write/execute test protocols and reportsRequired QualificationsMedical Device Quality experience (Ops or Manufacturing)Strong working knowledge of FDA/ISO regulations (13485, 14971, etc.)Ability to ramp up quickly3-5 years experience* LOCAL CANDIDATES TO WORK LOCATION (Santa Clara, CA) OR OPEN TO RELOCATE** NO C2C*Job Title: Quality Engineer Location: Santa Clara, CA (100% ON-SITE)ID# SEDAA 42840PAY RANGE: 50K - 70K/AnnumDescription: This position is Non-Exempt.