TSK Laboratory Europe B.V.
Quality Systems Engineer USA
TSK Laboratory Europe B.V., Irvine, California, United States, 92713
Develops, implements and maintains procedures for compliance with regulatory requirements, internal procedures & related documents to ensure effectiveness of quality system. Develops and implements systems to improve the detection and prevention of quality failures. Process improvements; analyzes nonconforming product/process/material issues. Understanding of the regulatory requirements (e.g. ISO/QSRs/MDSAP) and the ability to apply that knowledge to achieve regulatory compliance.
The TSK Group operates globally in medical technologies. Our focus is on innovation that supports both practitioner performance and patient experience—through constant iteration, smart engineering, and attention to detail. With operations across multiple global sites, we work as a close-knit, fast-moving team that values clarity, responsiveness, and accountability in everything we do.
Responsibilities
Document Control: initiate/review and maintain quality management system documents. Ensure stakeholders are adhering to company policies and procedures. Change Management: initiate/review, coordinate and track changes to approved procedures, processes, technical documentation. Review the change task completion. Track and support closure of change requests. Nonconformances and CAPAs: initiate/review, investigate, analyze root cause, report and monitor the events to support closure of nonconformances. Complaint handling and investigations: initiate, track and facilitate investigation with manufacturing sites and compile information for closure of complaint cases. Perform data entry, statistical data analysis, tracking, trending, creating graphs and reports as quired for QMS modules (e.g. NC, complaints, CAPAs, audits). Assess and process supplier change notifications including coordination for customer change approvals. Work closely with the Product Design Team, Quality, Regulatory and other departments to ensure that QMS requirements are effectively established and maintained, using a proactive and preventive risk-based approach. Perform product releases. Preform Quality review on technical documents such as validation, engineering drawings and technical specs. Support internal audits and readiness for both external and internal audits. Participate in supplier qualifications, reassessment activities, quality score cards. Qualifications
Bachelor’s degree in engineering, science or related field. 3 to 5 years’ experience in quality assurance, preferably in the medical device sector, or an equivalent combination of training and experience. Strong knowledge of ISO 13485:2016, MDSAP, QSR, MDR and ISO quality standards. Strong English communication skills, both verbal and written, across various organization levels. Knowledgeable in problem-solving techniques (e.g. root cause analysis, risk analysis, corrective actions, preventive actions). Experience in the application of statistics and data analysis to quality systems. Basic knowledge of medical device manufacturing processes and associated tools and test equipment (e.g. molding, assembling, packaging) and requirements for inspection and testing. Certified engineer preferred (e.g. ASQ, Exemplar, Certified Quality Engineer (CQE) and/or Regulatory Assurance Certification (RAC)). Ability to work collaboratively in a team environment. Willingness to be flexible and adaptable to changing priorities. Written and verbal communication skills in Japanese is an asset. Competitive salary based on experience Health, dental, and vision insurance 401K retirement plan with company matching An entrepreneurial team environment with real ownership of results We’re a team focused on delivering real value to our customers and investing in the growth of our people. If you are energized by solving problems, streamlining processes, and making a difference for our customers and our team every day, we want to hear from you. Equal opportunity employer
We value diversity and are an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, or protected veteran status. Disclaimer
This job description is not intended, and should not be construed, to be an all-inclusive list of all responsibilities, skills, effort, or working conditions as associated with a job. While this description is intended to be an accurate reflection of the job requirements, management reserve the right to modify, add or remove from particular jobs and to assign other duties necessary.
#J-18808-Ljbffr
Document Control: initiate/review and maintain quality management system documents. Ensure stakeholders are adhering to company policies and procedures. Change Management: initiate/review, coordinate and track changes to approved procedures, processes, technical documentation. Review the change task completion. Track and support closure of change requests. Nonconformances and CAPAs: initiate/review, investigate, analyze root cause, report and monitor the events to support closure of nonconformances. Complaint handling and investigations: initiate, track and facilitate investigation with manufacturing sites and compile information for closure of complaint cases. Perform data entry, statistical data analysis, tracking, trending, creating graphs and reports as quired for QMS modules (e.g. NC, complaints, CAPAs, audits). Assess and process supplier change notifications including coordination for customer change approvals. Work closely with the Product Design Team, Quality, Regulatory and other departments to ensure that QMS requirements are effectively established and maintained, using a proactive and preventive risk-based approach. Perform product releases. Preform Quality review on technical documents such as validation, engineering drawings and technical specs. Support internal audits and readiness for both external and internal audits. Participate in supplier qualifications, reassessment activities, quality score cards. Qualifications
Bachelor’s degree in engineering, science or related field. 3 to 5 years’ experience in quality assurance, preferably in the medical device sector, or an equivalent combination of training and experience. Strong knowledge of ISO 13485:2016, MDSAP, QSR, MDR and ISO quality standards. Strong English communication skills, both verbal and written, across various organization levels. Knowledgeable in problem-solving techniques (e.g. root cause analysis, risk analysis, corrective actions, preventive actions). Experience in the application of statistics and data analysis to quality systems. Basic knowledge of medical device manufacturing processes and associated tools and test equipment (e.g. molding, assembling, packaging) and requirements for inspection and testing. Certified engineer preferred (e.g. ASQ, Exemplar, Certified Quality Engineer (CQE) and/or Regulatory Assurance Certification (RAC)). Ability to work collaboratively in a team environment. Willingness to be flexible and adaptable to changing priorities. Written and verbal communication skills in Japanese is an asset. Competitive salary based on experience Health, dental, and vision insurance 401K retirement plan with company matching An entrepreneurial team environment with real ownership of results We’re a team focused on delivering real value to our customers and investing in the growth of our people. If you are energized by solving problems, streamlining processes, and making a difference for our customers and our team every day, we want to hear from you. Equal opportunity employer
We value diversity and are an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, or protected veteran status. Disclaimer
This job description is not intended, and should not be construed, to be an all-inclusive list of all responsibilities, skills, effort, or working conditions as associated with a job. While this description is intended to be an accurate reflection of the job requirements, management reserve the right to modify, add or remove from particular jobs and to assign other duties necessary.
#J-18808-Ljbffr