JUUL Labs is looking for a Senior Quality Engineer to join our Quality Systems team. Reporting to the Senior Manager, Quality Systems, they will assist in the implementation, management and continuous improvement JUUL Labs' Quality Systems to map with Quality System Regulation (§21 CFR 820) and ISO 13485, in addition to any applicable Federal and State compliance requirements specifically for Tobacco products. They will be responsible for assisting in the development of a compliant Quality Systems program and quality documents, and for assuring that quality data generated and submitted to regulatory agencies are valid and correct. Additionally, the Quality Engineer II must be able to guide and manage Quality System stakeholders through times of ambiguity and change, while maintaining support to business objectives.
Within a framework of ISO 13485:2016 and FDA 21 CFR parts 820/210/ 211, the individual will:
Develop written policies and procedures required for establishment of a Quality System suitable for FDA regulated electronic nicotine delivery systems (ENDS). Particular emphasis will be placed on supporting process and procedure for time-sensitive quality elements such as Design Change Control, Product Development, Risk Management and Post Market Quality processes and procedures.
Develop and acquire necessary tools and expertise to drive change control and risk management activities for quality assurance programs, policies, processes, procedures, and controls ensuring compliance to industry standards and strive for best in class quality system.
Drive, establish and support design compliance activities, post market surveillance and Quality System software validation activities.
Assure all products, processes and systems comply with JUUL Labs product development and change management policies, procedures, and specifications.
Review, analyze and report on quality related to process and product systems and guide development of disposition and corrective actions for recurring discrepancies.
Present performance metrics and status of critical issues to quality management.
Lead cross-functional problem-solving teams to drive process and product improvements; use of QA methodologies to manage and facilitate issue resolution including root cause investigations and the development, implementation, and monitoring of effective corrective and preventive actions.
Work with JUUL Management, Consultants, and Staff to develop practical solutions to achieve regulatory compliance and support quality process improvements.
Train Management and Staff on policies and procedures.
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
5+ years of Quality Systems experience working in an FDA regulated industry: medical device, pharmaceuticals, or combination products.
Knowledge of quality problem-solving methods including, but not limited to, Complaints root-cause investigations, CAPA/SCAR, NCR, fishbone diagrams, FMEA, process capability analysis, hypothesis testing, DoE, SPC, Lean manufacturing, Six Sigma. Additionally, evidence of the application of these methods to solve complex problems in a design center/manufacturing environment.
Detail oriented, ability to effectively handle multiple priorities, flexibility to reorganize and reschedule work on short notice to meet tight deadlines, have a strong quality mindset, and enjoy working in a team environment.
Ability to make decisions and take accountability for those decisions, with limited information, in high-pressure time limited situations.
Excellent verbal and written communicator; Demonstrated ability to communicate effectively across all business levels and functions, both internally and with external consultants/vendors.
Strong problem solving and interpersonal skills; Works with JUUL Management, Consultants, and Staff to develop practical solutions to achieve regulatory compliance and support quality process improvements.
Experience with high volume electronics in product manufacturing engineering, quality and/or testing roles is preferred.
Experience working with key manufacturing processes such as SMT, plastic injection molding, metal extrusion, and liquid filling is preferred.
Bachelor’s Degree in Engineering (Quality, Mechanical or Electrical preferred) or Applied Sciences preferred.
Internal Number: 1693
About JUUL Labs
JUUL's mission is to improve the lives of the world’s one billion adult smokers by driving innovation to eliminate cigarettes. JUUL is the number one US-based independent e-cigarette, selling over four million JUULpods per month. Headquartered in San Francisco and backed by leading technology investors including Tiger Global, Fidelity Investments and Tao Invest LLC, JUUL Labs is disrupting one of the world’s largest and oldest industries.We’re an exceptional team with backgrounds in technology, healthcare and biotech, and we’re growing rapidly to deliver on our mission. We’re actively looking to hire the world’s best scientists, engineers, designers, product managers, supply chain experts, customer service and business professionals.