OSI Systems, Inc

QA CAPA Specialist

2 weeks ago
Spacelabs Healthcare
Requisition #


At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.


Why work at Spacelabs? Because lives depend on you!



Spacelabs Healthcare is seeking a QA CAPA Specialist to review and evaluate CAPA records and ensure proper execution according to the CAPA procedure.


  • Develop and maintain CAPA procedures and work instructions
  • Ensure effective implementation of components of CAPA process, e.g. non-conformances, equipment out of tolerance findings, etc.
  • Monitor due dates of CAPA phases and follow up with CAPA Owners
  • Evaluate CAPAs for closure
  • Maintain CAPA Board Agenda and Meeting Minutes
  • Prepare weekly CAPA metrics for trending
  • Investigate, document, report, and track the root cause of quality issues
  • Establish appropriate corrective actions and improvements
  • Conduct CAPA process training
  • Evaluate the effectiveness and efficiency of regulated processes throughout the organization and makes recommendations for improvement
  • Assist in preparation and follow up for Management Review meetings
  • Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct.
  • Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
  • It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
  • Duties may be modified or assigned at any time to meet the needs of the business.


  • A Bachelor's degree in Business, or related field, or 4+ years equivalent experience in lieu of degree.
  • A minimum of 3 years’ experience in medical device industry or other regulated industries (e.g., FAA, etc.), preferably in a biomedical or technical role (level 2), or 5 years’ experience for a level 3. Overall relevant experience determines level.
  • Must be familiar with all elements of a Quality System, in particular the Corrective and Preventive Action sub-systems.
  • Must have experience with CAPAs as an owner and/or approver.
  • Knowledge of FDA’s 21 CFR 820 and ISO 13485 requirements preferred.
  • Must be highly compliance-oriented to firmly adhere to the principles of the regulations and standards.
  • Extremely well organized and able to manage multiple assignments/tasks with varying deadlines and requirements
  • Considerable interpersonal skills are mandatory, including relationship-building skills, and strong presentation and communication skills
  • Excellent computer skills, including Microsoft Office, Outlook, Internet Explorer and web conferencing software.


Equal Opportunity Employer


EEO is the Law


Poster Link: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf


OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.



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