Quality Manager 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

Fremont, CA

About The Role

The Quality Manager is responsible for developing, establishing, and maintaining quality systems needed for manufacturing and R&D operations. Oversee and implement an advanced level of quality systems for planning, and quality functions as they relate to product and manufacturing processes and ensuring compliance of our products and processes from development to post-market in a 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
• Assist manufacturing personnel to develop, establish and maintain work environment and infrastructure requirements
• Maintain a thorough knowledge of current QSR and ISO 9001 and ISO 13485 requirements
• Manage risk documentation to ensure proper documentation and mitigation of risks as it relates to processes
• Perform QA/QC inspections, as necessary
• 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, ISO regulations, Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem-solving techniques
• Review and approve process, test method, and equipment verification and validation protocols and reports, as needed
• Manage a team of Quality Engineers to ensure QMS is appropriately maintained and projects are delegated, as needed
• Responsible for QMS oversight and providing daily or weekly updates on QMS metrics to management
• Perform other related duties or special assignments as specified by manager
• Responsible for ensuring manufacturing procedures, inspection procedures, and work instructions are applicable and compliant with current operations
• Responsible for oversight of multiple quality management systems including CAPA, NCMR, RMA, Complaints, equipment control, supplier control, training, etc
• Assure all areas within Operations (i.e. manufacturing, inspection, incoming, inventory, etc.) are compliant and are maintained in an inspection-ready status
• Ensuring the promotion and awareness of customer requirements throughout the organization

Preferred Attributes

• Comfortable navigating ambiguity
• Self-starter mentality and an understanding of when to elevate key details for approval
• Ability to effectively juggle many priorities while remaining flexible to changing deadlines
• 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
• Interest in Hound Labs’ mission and desire to affect change
• Confidence to accept feedback
• Poise, resourcefulness, aptitude for problem-solving, and the willingness to suggest alternative approaches based on experience and research
• Ability to communicate efficiently with multiple people both internally and externally
• Intellectual curiosity, creativity, and eagerness to learn and teach

Qualifications

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

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 onsite

Physical Requirements

• 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
• Indoor position that requires sitting at computer for an extended period

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.