Quality Assurance Engineer
Permanent position: Leading Medical Device Manufacturer is seeking a Sr. Quality Assurance 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. You be drive Supplier and Production Quality improvements, including efficiency and productivity improvements while maintaining compliance. Relocation available for non-local candidates.
Responsibilities for the Quality Assurance Engineer
Requirements for the Quality Assurance Engineer
- 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.
- 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.