Sr. Quality Technician, Myra Vision

Myra Vision, a Shifamed Portfolio Company, is developing a treatment that safely and effectively reduces high intraocular pressure (IOP) for moderate to severe glaucoma patients. More than one third of glaucoma patients have moderate to severe disease, which requires significant reductions in IOP to reduce the risk of vision loss. To learn more about Myra Vision, please visit https://www.myravision.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.

Description

Our Sr Quality Technician will perform various detailed quality assurance duties including document review, inspection, and testing under limited supervision in accordance with company procedures.

As a key member of the team, you will participate in and drive design controls, design history file, design verification, and production and process controls. You will also play an active role in developing the Quality Management System and ensuring QMS compliance. This is a full time on-site position and will require reporting to our offices located in Campbell, CA.

Responsibilities, Skills & Hands-On Experience

• Review Device History Records (DHRs), incoming inspection records, and Product Release documentation, including device labeling accuracy, to ensure compliance with Quality System requirements. Notify management regarding discrepancies and nonconformities.

• 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.

• Support the building and release of sterilization loads, including documentation.

• Perform 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 and 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

• Review Device History Records (DHRs), incoming inspection records, and Product Release documentation, including device labeling accuracy, to ensure compliance with Quality System requirements. Notify management regarding discrepancies and nonconformities.

• 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.

• Support the building and release of sterilization loads, including documentation.

• Perform 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 and 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.

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 $70,000 to $95,000 + 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.