Software Quality Engineer

Tosoh Bioscience Inc., is a U.S. subsidiary of Tosoh Corporation's Bioscience Division, headquartered in Tokyo, Japan. Located in South San Francisco, CA, Tosoh Bioscience, Inc. is the leading provider of sophisticated medical diagnostic systems utilized by doctor's offices, hospitals, and reference laboratories throughout the United States. As the leader in clinical diagnostics, Tosoh's state-of the-art immunoassay analyzers and HPLC systems continue to meet the operational and economic needs of our customers. Tosoh remains at the forefront with a world class network of research facilities, scientists, engineers and customer support specialists. We have a solid commitment to provide Tosoh customers the best in clinical diagnostics.

Under the direction of the Senior Manager of Quality Assurance, performs critical Tosoh Bioscience Inc. (TBI)functions in support of TBI's Quality System in compliance with FDA Code of Federal Regulations (21 CFR 820), ISO 13485, 21 CFR part 11, ISO 14971, and Tosoh Bioscience Quality Policies and Procedures. The Software Quality Engineer develops, review and conduct activities related to the validation of automated systems and manufacturing, quality system and production instruments/equipment. This involves all regulated systems and processes through their life cycle including planning, requirements, specification, design, test, install and verification to establish and ensure compliance.


Under the direction of QA Management:

* Ensure that the Computer Systems Validation processes are compliant with the applicable regulations.

* Ensure that Computer Systems Validation deliverables and lifecycle processes are compliant with the Computer Systems Validation Policies and Procedures.

* Detect actual or potential conditions that could impact the quality, including deficiencies and system incompatibilities.

* Assure timely and effective preventative action by identifying root causes of issues and non-conformances.

* Ensure non-product software procured, acquired is assessed for intended use.

* Ensure Validation Status is maintained.

* Managing and implementing the non-product Software Quality Assurance program.

* Defining, approving, and implementing policies and procedures for all non-product software's lifecycle activities.

* Approval authority for all non-product software life cycle documentation.

* Establishing and maintaining a Software Change Control and issue management for regulated Computer Systems.

* Providing guidance to Supplier Quality when needed in the evaluation of software suppliers.

* Reviewing and approving all non-product software life cycle deliverables from a compliance perspective.

* Maintaining the System Inventory Spreadsheet.

* Providing guidance and assisting validation teams with maintaining compliance with Quality System Policy and associated Work Instructions.

* Submitting all approved lifecycle deliverables to Document Control.

* Supports other quality system processes as needed such as CAPA, investigations, internal & external audits, non-conforming material, risk management, process validation, design transfer and trending etc.

* Act as a subject matter expert (SME) in the software quality and software validation during the external ISO and FDA inspections.


* Minimum 5 to 9 years of experience of working in a Software Quality Engineer role within regulated industry (Medical Device, Pharmaceutical, Biotechnology)

* Knowledge of the medical device quality system regulations, especially for regulated software supporting the quality system and manufacturing across the enterprise.

* Working Knowledge of ISO 13485, 21 CFR 820, 21 CFR part 11 and Annex 11.

* Working knowledge of Principles of Software Validation FDA Guidance

* Working knowledge with various Software Technologies (e.g. ERP, Complaints, CAPA, Document Management Systems)

* Working knowledge of Change Control, Configuration Management, Software Development and Validation Life Cycle Methodologies.

* Working Knowledge of Infrastructure Controls for IT for Computer Systems

* Bachelors in Software Engineering, Information Management, Computer Science, etc.


Contribution is measured through, but not limited to, Quality System Metrics related to timely completion of equipment and computer validation, calibration, and routine maintenance, completion of equipment qualification, and results of internal and external audits of compliance with related policies and procedures.

Supervisory Responsibilities include:



The work environment characteristics described here are representative of those an employee encounters with performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Fumes, airborne particles, toxic chemicals are all potential elements of risk in performing job tasks related to servicing TBI analyzers/instruments. Although TBI provides all necessary equipment and training, there is an ever present bio-hazard danger in the work environment.

The job requires the employee to work under the following environmental conditions:

* Work near moving mechanical parts

* Work near fumes or airborne particles

* Work near caustic chemicals

* Work with risk of electrical shock

This position may require visits to customer sites which are medical facilities. These facilities may have certain requirements which TBI representatives must meet to gain access, including the requirement for drug, background, and health screening. Employment is contingent on your compliance with the requirements established by each facility, as evidenced by the results of the required screenings.

Note: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and / or ability required to be successful. Additional duties may be assigned in the future as required. Reasonable accommodations may be made for those individuals with disabilities in order to perform the essential functions.

Tosoh Bioscience, Inc. (South San Francisco, CA) employees enjoy a lucrative benefits package including medical, dental, vision, life insurance, various savings plans, extensive vacation pay, retirement package, competitive salary, bonuses, and an amazing work-life balance.

TBI is an Equal Opportunity Employer M/F/Disabled/Veterans.

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