Quality Manager

Location

Kirkland, WA | United States

Job description

The Scoop

We’re on the lookout for a data-driven Quality Manager to join our growing team. This position is responsible for providing organizational leadership for the overall quality management system and regulatory affairs in alignment with Katalyst’s mission, strategy, and organizational goals. The Quality Manager will oversee, create, and drive the vision and implementation of robust quality systems, including quality assurance of records, quality control, document control, process validation, supplier qualification, auditing, and nonconformance and occurrence management with CAPA and RCA. This position will collaborate with the Hardware, Software, and Executive Team as it relates to the organization’s quality improvement process and will ensure that quality systems data is collected and analyzed, and that quality goals are created and monitored for ongoing improvement in Katalyst’s pursuit of excellence.You’ll play a key role in Katalyst’s success transforming the health and fitness industry.

About Us

Founded in 2015, Katalyst is a groundbreaking, full-body Electro-Muscle Stimulation (EMS) workout that is designed to enhance your fitness at every stage of life. Our FDA-cleared EMS technology works with your body rather than against it, delivering personalized and efficient strength, power, cardio, and recovery workouts in just 20 minutes or less. 

We’re ready to continue to build our small but mighty team. If you’re excited by innovative technology, enjoy solving problems in an agile environment, and are passionate about building a world class organization from the ground up, we want to hear from you! Learn more at .

Responsibilities:

• Own the functioning of the EQMS system
• Drive document completeness for both completed and ongoing projects
• Design Controls - Participate in hardware and software design meetings and collaborate with hardware and software teams to create lean processes and documentation creation that conforms to regulatory requirements 
• Supplier Controls - Participate in supplier meetings and collaborate with supply chain to create lean processes and documentation creation that conforms to regulatory requirements 
• Lead risk analysis and CAPA activities
• Complaint handling - Collaborate with Member Experience and create and manage lean and scalable processes for complaint handling
• Work with external compliance companies on an ongoing basis
• Organize and lead regular internal quality system and compliance audits
• Lead and represent the company in FDA audits

Requirements

• Bachelor’s Degree in Engineering, related field or equivalent experience

• Proficient and previous experience in a validated QMS, bonus points for AODocs experience
• Knowledge and experience with firmware or software, and/or hardware development and the processes associated with product life-cycles
• Open to learning new areas - Electronics, Mechanical, Apparel, Firmware and software
• Experience with Agile Software Development and FDA regulated software
• 5+ years experience within FDA regulated environment, 3 years within a Quality related field
• Strong Working knowledge of medical device regulations (including FDA QSRs, ISO13485)
• Strong working knowledge of design controls and design transfer requirements
• Ability to create and review documentation to meet internal and regulatory requirements
• Excellent verbal and written communication skills
• Experience with CAPA processes including investigational techniques
• Familiar with one or more risk management techniques (i.e. Hazard Analysis, Risk Analysis, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), etc.)
• Able to work, influence and lead in a highly cross-functional team environment
• Educating people from non-medical device background on regulatory requirements and assisting them to adhere to those requirements
• Proven experience with FDA audits
• Ability to work independently on tasks as a subject-matter expert and report progress

Benefits

At Katalyst, the health and well-being of our employees are of the utmost importance to us. We offer the following to all full-time employees:

• Competitive salary and stock options
• Medical, Dental, and Vision
• 401k with employer match
• Unlimited PTO
• Hybrid work environment with 2 days in office per week
• Parental/Family leave

The salary range for this role is $110,000 - $140,000 + equity.

This range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and business needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.

Katalyst is an equal opportunity employer and committed to creating an inclusive environment for all of our applicants. We do not discriminate based upon race, religion, color, national origin, gender, sexual orientation, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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Salary