Sr. Quality Assurance Engineer

This position requires a fully bilingual english/spanish speaker and writer with excellent communication skills. This position also requires monthly travel to the Caribbean between the two plants working on-site at both locations. The candidate that will succeed in this position will be someone with strong, diverse quality experience providing strong leadership to continuously improve quality objectives at two separate plant facilities. Must have the ability to work on multiple projects at once. It is key that this individual will be able to quickly orientate themselves with two different company teams and quality systems in order to take over FULL RESPONSIBILITY for both departments in the medical manufacturing facility and the metal component fabrication facility. Responsible for working to improve the company's best practices through maintenance and creation of ALL necessary quality system documents and processes including but not limited to:

Responsibilities

• Competency to read, verify and/or modify engineering drawings as needed
• Create design review documentation
• Identify, and address quality control performance/needs
• Issue, write effective CAPA's including to conduct investigations as needed
• Perform regular trending analysis
• Monthly review, managing of all complaints
• Perform gap analysis when needed
• Maintain calibration of all equipment and logs appropriately
• Perform risk analysis in support of new product development
• Establish or enhance operational controls for each process
• Write verification and effectiveness of actions to address risks
• Follow up on CAPA's to verify sustainability and personnel compliance
• Write or improve work instructions when needed
• KPI analysis of manufacturing processes
• Work closely with manufacturing personnel to ensure quality protocols are followed and documentation properly maintained
• Lead all company audits, FDA and ISO
• Work closely with C level management to support quality system needs while enhancing product, company success
• Assure consistent compliance of changing regulatory landscape
• Develop or Evaluate testing processes, make recommendations as necessary
• New product validation
• Perform and Closeout all internal audit activities per class II medical requirements
• Lead FMEA and risk analysis
• Issue non-conformances or Ecr's as needed
• Inspection and testing of various parts manufacturing including products, componenets, processes and comparing with predefined standards
• In charge of OSHA certification
• Improve written procedures when needed
• Serve as management representative

Qualifications

• Bachelor's degree in Quality engineering or other Quality training
• 7+ years relevant quality assurance mangement experience
• Auditor certification
• Business management experience a plus
• Team player

Job Types: Full-time, Part-time

Pay: From $80,000.00 per year

Benefits:

• Paid time off

Experience:

• ISO 9001: 5 years (Required)

Language:

• English (Required)

License/Certification:

• Certified Quality Auditor (Preferred)

Ability to Relocate:

• Atlanta, GA: Relocate before starting work (Required)

Willingness to travel:

• 50% (Required)

Work Location: In person