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Quality Assurance Specialist Jobs

Company

Henry Schein
Address , Placentia
Employment type FULL_TIME
Salary
Expires 2023-10-09
Posted at 9 months ago
Job Description
KEY RESPONSIBILITIES:
  • Support the Corrective Action program, with hands on ownership for investigation, root cause analysis, and resolution of issues.
  • Assist and maintain sitewide training on general quality principles and specific procedural requirements.
  • Review and maintain quality records and documents, for completeness and compliance with Quality System, ISO, and other international regulations.
  • Ensures established timelines are met.
  • Support the Material Review Committee, for the assessment and disposition of non-conforming materials and closure of Non-conformances.
  • Assist in the development of standard operating procedures, work instructions, and risk assessments for continuous improvements to current production capabilities.
  • Manage and maintain post-market surveillance activities.
  • Assist, coordinate and participate in both internal and external quality system audits and regulatory inspections.
  • Provide Quality support in the development, implementation and monitoring of new continuous improvement strategies pertaining to operation capabilities.
  • Conduct process quality measurements/evaluations, including assist in monitoring, analyzing and reporting trends in key quality metrics.
  • Other activities as assigned by the Manager of QA/RA
  • Perform Process validations, in particular to IQ, OQ, PQ.
SPECIFIC KNOWLEDGE & SKILLS:
  • Experience with ISO 14971 Risk Management is a plus.
  • Ability to prioritize, multi-task and adapt to change.
  • Providing quality support to medical device production and repair functions with little supervision.
  • Relevant experience in the medical device industry is required.
  • Experience in Process Validations (IQ, OQ, PQ)
  • Familiarity with FDA medical device regulations and ISO 13485 is required.
The posted range for this position is $54,000 to $94,5000 which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.
Vaccine Requirement
Candidates for this requisition are required to be fully vaccinated against COVID-19 (i.e., 2 weeks after completing their initial COVID-19 vaccination series) pursuant to state/local law. These standards and/or requirements may vary from those established by the Company. In some jurisdictions there may be an exception for those seeking a medical or religious accommodation. If you require an accommodation, please inform the recruiter or hiring manager.
Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers