Quality Engineer, Manufacturing Jobs

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
Newark, CA and 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

• Provide quality training to site staff and new hires in the use of the quality system and associated requirements.
• Responsible for ensuring complaints are appropriately logged, evaluated, investigated, and documented.
• 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.
• Assist manufacturing personnel to develop, establish and maintain work environment and infrastructure requirements.
• Assists with the development of manufacturing procedures, inspection procedures, and implementation of the manufacturing process.
• Perform other related duties or special assignments as specified by manager.
• Responsible for ensuring nonconformances are processed in accordance with SOPs, including investigation, disposition, segregation, and that appropriate records are completed.
• Gather quality metrics and analyze for trending and inclusion into Management Review and the CAPA process, as necessary.
• 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.
• Perform and document investigations related to processes and quality systems, as needed.
• Assist with design transfer to ensure all requirements are effectively implemented within Operations.
• Ensuring the promotion and awareness of customer requirements throughout the organization.
• Perform QA/QC inspections, as necessary.
• Assist with CAPA initiation, investigation, and verification of effectiveness, as needed.
• Manage risk documentation to ensure proper documentation and mitigation of risks as it relates to processes.
• Responsible for equipment control, including preventive maintenance, calibration, and qualification activities.
• Maintain a thorough knowledge of current QSR and ISO requirements as they apply to the medical device industry.
• 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.

Preferred Attributes

• Ability to effectively juggle many priorities while remaining flexible to changing deadlines.
• Confidence to accept feedback.
• Self-starter mentality and an understanding of when to elevate key details for approval.
• Comfortable navigating ambiguity.
• Intellectual curiosity, creativity, and eagerness to learn and teach.
• Ability to communicate efficiently with multiple people both internally and externally.
• Great work ethic, ability to adapt quickly to changing priorities and shifting workloads, and an eye for making decisions that ensure the success of key internal and external stakeholders.
• Poise, resourcefulness, aptitude for problem solving, and the willingness to suggest alternative approaches based on experience and research.
• Interest in Hound Labs’ mission and desire to affect change.

Qualifications

• Experience with Medical Devices quality management systems standards (e.g. ISO 13485)
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Bachelor’s degree in engineering or equivalent discipline or equivalent work experience
• ASQ certification a plus
• 5+ years of Quality Engineering experience within a medical device manufacturing environment required.
• Must be comfortable in a fast-paced small company environment with changing priorities

POSITION | EXPECTED HOURS OF WORK

• Occasional evening work may be required as job responsibilities demand.
• Days and hours of work may be variable depending on business need.
• Full-time position.

Physical Requirements

• Indoor position that requires sitting at computer for an extended period.
• Exposure to moderate to loud noise and light as typical in a manufacturing environment.
• Travel to vendors, conferences, company meetings, and other events may be required.

The HOUND® CANNABIS BREATHALYZER is intended to detect recent cannabis use. It does not measure whether, or how much, a person is impaired. It is intended solely for use in law enforcement, employment, and insurance settings. It should not be used for any medical or therapeutic purposes, or for any Federal drug testing programs, such as programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.
Diversity is important at Hound Labs. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.