Quality Inspector (IVD Device) - 11418

Quality Inspector (IVD Device) - Simply Biotech

OVERVIEW

Are you looking for a new Quality Inspector career opportunity with an exciting clinical and diagnostic life science detection company that’s creating the new standard of merging silicon biosensor technology and established biological techniques that provides rapid diagnostic testing solutions for doctors, patients, and researchers?! THEN READ ON! In this role, you’ll be responsible for supporting incoming part and material inspections, NCMR generation, and participates in Material Review Board (MRB) activities as required. The Quality Inspector will use test equipment and precision measuring instruments to determine material and part acceptability and compliance with specifications. Our client is offering generous compensation, excellent benefits, fast-track career progression, and a lot more! 

Immediate opening for a Quality Inspector in San Diego, CA who possesses:

• 3+ years of experience with incoming inspection of electromechanical parts and materials in the medical device or diagnostic industry 

• Experience using inspection measurement tools such as digital calipers, micrometers, height, pin gages, dial indicator, and gage blocks.

• Solid understating of Geometric Dimensioning and Tolerancing (GD&T), interpreting mechanical drawings, defining measurement techniques, performing inspections and documenting data.

• Experience working under quality standards and quality regulations associated with the medical device/diagnostic fields (ISO 13485 and 21 CFR 820)

• OGP SmartScope experience is MAJOR a plus (if they don’t have, they’ll train candidates up in LA for about a week) 

• Associates Degree is a plus, but not required 

Email resumes to mturner@SimplyBiotech.com and call 858.356.6772

Key responsibilities include:

• Perform incoming inspections of mechanical and electronic parts/materials required to support ongoing medical device and assay development and manufacturing activities.

• Perform incoming part, first article, and material inspections in accordance with company procedures and applicable ISO standards.

• Generate NCMR, quarantine parts and materials, and track suspect material to resolution when discrepancies are identified, develop solutions and create opportunities for improvement. 

• Contribute to the management of Quality Events such as Non-conformances and Corrective and Preventive Actions (CAPA), and Supplier Corrective Action Requests (SCARS) to meet company objectives. 

• Maintain compliance with all company policies, quality system, and procedures.

• Maintains appropriate documentation related to quality assurance tests and inspections. 

• Ensures all inspection documents are accurate, organized, filed appropriately within the eQMS system as appropriate.  

For immediate and confidential consideration, please email your resume to mturner@SimplyBiotech.com  and call 858.356.6772 

More information can be found at www.SimplyBiotech.com