Shifamed LLC is Hiring a QC Inspector, Atia Vision Near Campbell, CA
Atia Vision, is a Shifamed Portfolio Company that is committed to improving patient outcomes by developing a safe and controllable presbyopia correcting IOL that aims to restore the full range of functional vision in cataract patients, the largest segment of the ophthalmology market. To learn more about Atia Vision, please visit www.atiavision.com.
ABOUT SHIFAMED
Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
The Quality Inspector is responsible for performing quality inspections and testing under limited supervision in accordance with company procedures.
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
Proficient use of microscopes, calipers, pin gauges, rulers, and computer software such as Excel and Word. Experience using tensile testers and video inspection systems preferred.
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 $60,000 to $70,000 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.