Quality Inspector/Technician, Tioga Cardiovascular

Tioga Cardiovascular, a Shifamed Portfolio Company, is developing a minimally invasive, transcatheter mitral valve replacement therapy that is both easier to use and implantable in a higher percentage of patients with mitral regurgitation. To learn more about Tioga Cardiovascular, please visit www.tiogacardiovascular.com.

ABOUT SHIFAMEDFounded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical technology incubator focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

DescriptionThe Quality Inspector/Technician is responsible for performing quality inspections and testing under limited supervision in accordance with company procedures.

As the key member of team, you will actively drive design controls, design history file, risk management, design verification protocols and testing. This position also represents an opportunity to influence the design selection, optimization, specifications, and test development and enable patient safety, quality, and reliability in the early designs. This position will also play an active role in developing quality management system and ensure QMS compliance adherence. This is a full time on-site position and will require reporting to our offices located in Los Gatos, CA. Responsibilities, Skills & Hands-On Experience:Perform inspection/testing activities pertaining to in-process, final packaging, and design verification and process validation testing. Generate detailed and accurate inspection and testing reports in accordance with Current Good Manufacturing Practices (cGMP) and company Quality Management System requirements.Review Device History Records (DHRs) and Product Release documentation to ensure compliance with Quality System requirements. Notify management regarding discrepancies and nonconformities.Support the building and release of sterilization loads, including documentation.Assist Quality Assurance with Incoming Inspection of supply items and components, as needed, including First Article Inspections.Assist with Receiving and Shipping activities, as needed. Duties may include receiving materials, delivering packages, preparing shipping labels, packing lists and packaging outgoing shipments.Assist Operations with Inventory Management activities, as needed. Duties may include counting inventory for supply items, components, and subassemblies, maintaining an inventory log, and providing Purchasing with accurate reorder data.Maintain and operate inspection and test equipment.Support the Engineering team with projects, as needed.Perform other duties as assigned.

Education & Work Experience:High School Diploma required.Minimum of 3-5 years of experience performing inspections; medical device industry experience preferred.Must have excellent hand/eye coordination, manual dexterity, and vision corrected to 20/20.Must have attention to detail and be able to document inspection results clearly and accurately.Experience using vision measurement system, MicroVu preferred.Proficient use of common equipment, such as microscopes, calipers, micrometer, snap gauge, pin gauges, rulers, etc.Experience using tensile testers preferred.Proficient with computer software such as Excel and Word.Excellent communication skills required (verbal and written).Ability to read English and comprehend verbal and written instructions. Ability to read and interpret engineering drawings preferred.Must be able to wear protective garments such as a coveralls/lab coat, shoe covers, hair covers, and gloves for extended periods.Must be able to work independently or in a team setting.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $68,000 to 75,000 + equity + benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com