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
- 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)
- 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
- Company sponsored benefits package.
- 401K with company match
- Relocation available for non-local candidates.
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.