12 months contract to start with (extendable contract)
This is a mid-level Quality Engineering position that requires an individual with medical device design control background and validation/qualification knowledge/experience in a regulated environment, e.g., IVDD, Medical Device, Pharmaceutical, Biotech, etc. The individual in this role will be responsible for supporting various quality engineering activities as part of the China expansion project. This position is based in Walpole, MA and reports into the China expansion Sr. Quality Manager, also based in Walpole
In this role the individual will be responsible for driving individual immunoassay Design History File (DHF) gap analysis and mitigation; leading or participating on individual validation and qualification activities for process, equipment, facilities and utilities of an IVD manufacturing facility to be built in China. Will work closely with the other project core team leads/functions, e.g., Manufacturing, Technical Operations, Engineering and Quality Assurance, to ensure that processes are appropriately qualified/validated in a timely manner. In addition, the individual will provide supports on other quality engineering activities such as Product Technical Requirement (PTR) development and testing, Product Performance Evaluation (PPE) strategy development, Packaging development and testing, Risk Management gap closure as needed.
Specific responsibilities include but not limited to:
Drive individual immunoassay Design History File (DHF) gap analysis and develop mitigation plan
Support Risk Management activities such as developing dFMEA and pFMEA
Support in development of Site Validation Master Plan.
Create and develop individual qualification and validation protocol and report
Work with Engineering on specific equipment, facility and utility validation plans and reports.
Supports on other quality engineering activities such as Product Technical Requirement (PTR) development and testing, Product Performance Evaluation (PPE), Packaging development and testing, in-house label development and testing as needed
Ensure that all qualification/validation plans, protocols and reports are complete, accurate and compliant with applicable requirements, including those of the China FDA.
May require some travel to China.
Required Knowledge/Skills, Education, and Experience
Experience: A minimum of 5 years in the medical device, biotechnology or pharmaceutical industry, with a Quality Engineer or Validation Engineer role.
Education: A minimum of a 4 year degree is required.
Knowledge of CFR 21 Part 820 (QSR), ISO 13485, ISO 14971, CMDCAS, MDD 93/42, PAL, and other domestic and international regulations that may apply
Experience in Design Control and risk management
Experience in the application of production and process controls including process validation, test method validation, process control plans, statistical process control, risk management and statistical tools.
Excellent verbal and written communication skills.
Must be able to work collaboratively with other project team members.
Preferred Knowledge/Skills, Education, and Experience
Prior experience with facility start-up/qualification projects.
A quality engineering certification from the American Society for Quality other qualifying organization is required. Examples include the CQE, CRE, etc.
Fluent in Chinese is a plus
Knowledge of CFDA IVD GMP requirements
Prior experience in an IVDD manufacturing environment
Thanks and Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com