Quality Engineer, Manufacturing

ABOUT HOUND LABS, INC.

Hound Labs, Inc. is a team of scientific technology innovators whose ultra-sensitive, automated, and analytical solutions solve relevant public health and safety issues. Later this year, Hound labs will launch the HOUND® CANNABIS BREATHALYZER, the first solution to use the company’s breakthrough technology to help employers and law enforcement identify recent cannabis use in the breath on location within minutes. Dr. Mike Lynn, emergency room physician, reserve deputy sheriff, and former venture capitalist, founded Hound Labs, Inc. in 2014. Benchmark, EEC, Icon Ventures, Intrinsic Capital Partners, NFP Ventures, Tuatara Capital, and individual investors have funded the Company.

DEPARTMENT

Quality & Regulatory

REPORTS TO

Director of Quality Management Systems

LOCATION

Fremont, CA

ABOUT THE ROLE

The Quality Engineer is responsible for developing, establishing, and maintaining quality systems needed for manufacturing operations. Oversee and implement an advanced level of quality systems for planning, quality functions as they relate to product and manufacturing processes and ensuring compliance of our products and processes from development to post-market in medical device regulated environment.

OVERVIEW OF RESPONSIBILITIES AND DUTIES

• Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations, Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem-solving techniques.
• Assists with the development of manufacturing procedures, inspection procedures, and implementation of the manufacturing process.
• Assist with design transfer to ensure all requirements are effectively implemented within Operations.
• Assist manufacturing personnel to develop, establish and maintain work environment and infrastructure requirements.
• Responsible for ensuring nonconformances are processed in accordance with SOPs, including investigation, disposition, segregation, and that appropriate records are completed.
• Responsible for ensuring complaints are appropriately logged, evaluated, investigated, and documented.
• Responsible for equipment control, including preventive maintenance, calibration, and qualification activities.
• Assist with CAPA initiation, investigation, and verification of effectiveness, as needed.
• Responsible for evaluating suppliers in accordance with SOPs for inclusion onto the Approved Supplier List (ASL), ensuring all documentation and records are complete and meet requirements.
• Review and approve process, test method, and equipment verification and validation protocols and reports, as needed.
• Provide quality engineering support for quality, manufacturing, design & development, documentation, and other product related disciplines.
• Assure all areas within Operations (i.e. manufacturing, inspection, incoming, inventory, etc.) are compliant and are maintained in an inspection-ready status.
• Gather quality metrics and analyze for trending and inclusion into Management Review and the CAPA process, as necessary.
• Perform QA/QC inspections, as necessary.
• Provide quality training to site staff and new hires in the use of the quality system and associated requirements.
• Ensuring the promotion and awareness of customer requirements throughout the organization.
• Perform and document investigations related to processes and quality sy