Job description

Job Description

Client is developing and commercializing a uniquely powerful cell processing platform that is set to transform the manufacturing of novel cancer immunotherapy products. Our Cell Processing System enables cell separation with virtually no cell loss and is poised to radically improve patient outcomes and the economic landscape of cell therapy. Designed with both manufacturing and clinical potential at the forefront, the System enables production of CAR-T and other cell therapies beyond today’s limitations.

We are seeking a Senior Quality Engineer with a minimum of 8 years’ experience in a regulated industry and a passion for shepherding new products to market.

Job Responsibilities

· Oversee and manage design transfer and process transfer activities for a consumable product produced at a Contract Manufacturer (CMO) site in Brea, CA.

· Provide engineering support and lead troubleshooting activities on the production line. Perform systematic and documented Root Cause Analyses for failures and implement Corrective Actions.

· Perform analysis to understand and improve processes, reduce failures, and improve yields.

· Participate in design reviews and pre-validation assessments of new products and processes, and ensure the process has adequate and appropriate process controls.

· Work with Product Development team to ensure all aspects of Design Transfer activities are being met and comply with the requirements of the quality management system and external regulatory agencies

· Ensure that all equipment, instrumentation, and software is maintained in a validated state. Ensure compliance with current regulatory requirements.

· Review proposed changes by performing risk assessments, providing guidance, support, and assessing the adequacy of verification and validations and DHF documents

· Participate in and author sampling plan development and data analysis for design verification, new/existing product test methods and incoming inspection; ensure predetermined requirements are met

· Communicate results effectively, guiding the team through data and observations on critical process decisions.

· Coordinate with cross-functional project teams to ensure timelines are met and assist the team to balance costs, timeline, and performance.

Qualifications

· Bachelor’s degree (B.S.) or Masters degree (M.S.), preferably in a scientific discipline or life sciences

· Strong analytical, planning, and organizational skills

· Technical and administrative abilities required to carry out routine job requirements.

· Excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management.

· Ability to communicate ideas and knowledge effectively and clearly to other individuals and teams.

· Excellent problem-solving skills

· Self-starter with ability to work independently under pressure and react quickly to changing priorities

· Mentor team members in qualification/validation technical aspects, and compliance requirements

Experience

· Eight (8) years minimum direct applicable experience, with relevant experience in medical devices regulated environment

· Working experience in medical device industry with knowledge of FDA’s guidance documents and regulations, ISO and ASTM standards related to quality and medical device and IVDs

· Thorough understanding of industry regulations: cGMP, ISO QM Standards (21CFR820, ISO13485)

· Knowledge of design control principles

· Thorough understanding of Statistical Methods for Quality Assurance

Job Type: Full-time

Salary: $100,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Carlsbad, CA 92008: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Experience:

• Medical Devices: 8 years (Required)

Work Location: One location

Speak with the employer
+91 +13023215960

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