Quality Assurance Engineer- Medical Devices

Tosoh Group America Grove City , OH 43123

Posted 2 weeks ago

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, the Quality Assurance Engineer 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, ISO 14971, and Tosoh Bioscience Quality Policies and Procedures. The Quality Engineer assists in the implementation, management and continuous improvement of the TBI Quality System and provides cross-functional engineering support to Operations, Facilities Control and Manufacturing Project teams through system validations and data monitoring.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Under the direction of QA Management:

  • Manage the nonconforming product process which includes, but is not limited to, scheduling of material review board meetings, following up on action items, and ensuring timely closure of nonconforming product reports.

  • Assists scientific staff in identifying and documenting requirements for new instruments, medical devices, and equipment to ensure that each meet required specifications.

  • Assist in CAPA process as needed to investigate, propose corrective and preventive actions and verification of CAPAs to ensure timely closure

  • Ensure approved manuals and software are duplicated, reviewed and approved in a timely manner.

  • Perform quality reviews of duplicated software

  • Heavily involved in the change control process when related to the revision or creation of new software.

  • Generates Risk Management Assessment reports for Equipment and Engineering Plans along with SME.

  • Prepares protocols for installation, operational and performance qualification of instruments, performs and/or directs the execution of these protocols and completes the final validation reports.

  • Performs quality testing on devices to determine engineering tolerances and validation schemes.

  • Assists in the development of the TBI Master Validation Plan with SME.

  • Writes Quality System procedures for instrument operation, routine maintenance and calibration.

  • Assists with environmental control monitoring system, and coordinates responses and corrective actions and preventative actions to alarms and out-of-specification conditions.

  • Responds to equipment malfunctions and coordinates repairs performed by external vendors.

  • Trains TBI employees in the operation of new laboratory equipment and response to environmental monitoring system alarms.

  • Maintains detailed equipment records on the purchase, qualification, calibration, repair and maintenance in compliance with documented Quality System procedures.

  • Assists in internal audits and external ISO and agency inspections to assess TBI compliance with Quality System policies and procedures as needed.

  • Assists in the development and monitoring of quality metrics, trending of process

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Bachelor's Degree is preferred in a technical discipline such as biomedical sciences engineering, engineering, or a related field and/or equivalent experience.

  • Five (5) to Ten (10) years of relevant medical device quality experience (experience in IVD would be a big plus) in an FDA-regulated or ISO13485 environment with exposure to cGMP practices.

  • Ability to understand Distribution/Contract manufacturing versus Manufacturer of Record quality and regulatory cGMP requirements for Facilities, Operations, and Manufacturing of Clinical Chemistry IVDD.

  • Organizational, planning and detail follow-up skills required. Ability to utilize tasking, scheduling, and other project management tools.

  • Training and experience in use of statistical analysis tools and test method development a plus.

  • Ability to work independently and motivational talent required with ability to relate to team members as well as others across other functional teams within the organization.

  • Ability to handle and resolve conflicts

  • Demonstrated ability or track record of successful results

  • Attention to detail and timeliness are critical.

  • Excellent communication (verbal and written) and interpersonal skills required.

  • ISO 13485 Lead Auditor certification strongly preferred

MEASURES OF CONTRIBUTION/IMPACT:

Contribution is measured through, but not limited to, Quality System Metrics related to timely completion of equipment 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:

N/A

WORKING CONDITIONS:

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.

  • Must agree to provide required immunization records and/or agree to acquire required immunizations in order to gain access to customer sites as required by customers. You may be required to register at vendor credentialing

  • Up to 15% travel required

PHYSICAL AND ENVIRONMENTAL DEMANDS:

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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Quality Assurance Engineer- Medical Devices

Tosoh Group America