Senior Quality Assurance Engineer Lead

Tosoh Bioscience, Inc., based in South San Francisco, CA is a U.S. subsidiary of Tosoh Corporation's Bioscience Division, headquartered in Tokyo, Japan. Established in the United States in 1989, Tosoh Bioscience has become known throughout the Americas for providing sophisticated diagnostic systems to doctor's offices, hospitals and reference laboratories. Tosoh remains at the forefront with a world class network of research facilities, scientists, engineers and customer support specialists.

Summary

Under the direction of the Senior Manager, Quality Systems and Compliance, this position 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 13485:2016, MDSAP, ISO 14971, and Tosoh Bioscience Quality Policies and Procedures. The Senior Quality Assurance Engineer Lead assists in the implementation, management and continuous improvement of the TBI Quality System and leads and provides cross-functional engineering support to Operations, Facilities Control and Manufacturing Project teams through system validations and data monitoring.

Reporting Relationships

The Senior Quality Assurance Engineer Lead will report to the Senior Manager, Quality Systems and Compliance. This position will have a team of direct reports.

Major Duties and Responsibilities

• Demonstrates an understanding of the regulatory and Company requirements and to perform gap assessments to those requirements.
• Manage and or support internal audits, supplier audits, NC/CAPA, quality agreements.
• Support Third Party Audits for FDA, and MDSAP as backroom coordinator and Subject Matter Expert.
• Review, establish, maintain, and report, monthly and quarterly, Quality metrics for the organization and QMS system.
• Perform investigations analysis independently including gap assessments and root cause analysis evaluations to determine risk level utilizing root cause analysis tools.
• Uses technical, scientific, and professional judgment for assessing the effectiveness of CAPAs and communicates to supervisor and area management when deficiencies are found.
• Ensures that CAPA, non-conformance, and supplier records are accurate , complete, and contain correct references to Quality documents, and or processes such as Change Management, Audits, Non-Conformances, and Complaints.
• Critical Review of documents and document change requests. Experience in assessing the weight of evidence associated with a claim/hypothesis/ assertion is preferred.
• Ensures the best level of service in compliance with reference rules and standards
• Ensuring the level of scientific and technical skills necessary for the performance of your tasks
• Contributes to business development and image/branding of the company.
• Other duties as assigned, according to the changing needs of the business

Education

• Bachelor’s degree in industrial technology, Biology, Chemistry, Biochemistry, Electrical/Electronic/Mechanical or Bioengineering.

Skills and Qualifications

• Minimum 8 years’ experience in the field of medical devices and healthcare products or related medical device manufacturing, auditing, or Quality Assurance. Full time hands-on direct work experience can be in one or more of the following: (manufacturing, Quality Systems implementation/maintenance, compliance with relevant national or international standards; performance testing, evaluation studies or clinical trials of the devices)
• Managing direct reports experience required.
• Proficiency in Office Applications required.
• SmartSolve software or equivalent Quality Management system experience required.
• Understanding of quality concepts such as: cost of quality, analytical metrics, statistics and trending, quality planning, validation, CAPA and problem solving
• Management of third party audits/inspections, internal audits, supplier audits, document control, change control, training, NC/CAPA, quality agreements, training employees.
• HIPPA Compliance
• Experience creating employee development plans.

Physical Requirements

• This is a largely sedentary role
• While performing the duties of this job, the employeeis regularly required to talk or listen.
  • Must have close visual acuity to perform activities such as: preparing and analyzing data, transcribing, viewing a computer terminal, extensive reading.
• Must have the ability to travel occasionally by either auto or air.

Tosoh Bioscience, Inc. is an Equal Opportunity Employer M/F/Disabled/Veterans