Quality Assurance Engineer

  • location: Fort Lauderdale, FL
  • type: Permanent
  • salary: $76,000 - $96,000 per year
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job description

Quality Assurance Engineer

job summary:
Permanent position: Leading Medical Device Manufacturer is seeking both a Mid-Level and Sr. Quality Engineer in South Florida. The employee will be responsible for supporting the quality engineering operations of receiving inspection, in-process and finished product and maintaining processes and methods in accordance with the company standards. Relocation available for non-local candidates.

 
location: Fort Lauderdale, Florida
job type: Permanent
salary: $76,000 - 96,000 per year
work hours: 8am to 5pm
education: Bachelors
 
responsibilities:
Responsibilities:

  • Participates in the non-conformance process to ensure timely completion of documentation stages
  • Identifies, Reports and Monitors Nonconforming events for the areas of responsibility
  • Performs product or process failure investigations and implements corrective and preventive actions to prevent reoccurrences
  • Quality control, product release authorizations, and quarantine of all suspect or discrepant product.
  • Collaborates with Manufacturing, Product Support and R&D to support products for design and process improvements, and new equipment installations
  • Provides adequate QA support to the assigned areas and responds to Internal Audits, and takes actions as appropriate based on CAPAs, Complaint investigations, Nonconforming events, etc.
  • Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ)
 
qualifications:
Requirements:

  • Bachelor's degree in a technical discipline (Mechanical/Biomedical/Electrical engineering), or equivalent, with a minimum of five years of experience in medical device quality assurance.
  • 5+ years experience - ideally with some Class III med devices
  • Understanding of quality system regulations (ISO13485, 21CFR820)
  • Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) - ISO 13485 and ISO 14971).
  • Understanding of required standards / regulations impacting Medical Devices.
  • Six Sigma Certification and ASQ Quality Engineer Certification are a PLUS
 
skills: Benefits

  • Company sponsored benefits package.
  • 401K with company match
  • Relocation available for non-local candidates.
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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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