OSI Systems, Inc

QA CAPA Specialist

US-WA-Snoqualmie
2 weeks ago
Spacelabs Healthcare
Requisition #
12492

Overview

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.

Responsibilities

  • 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.

Qualifications

  • 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.

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for general consideration.