Supplier Quality Auditor
- San Francisco, CA
JUUL Labs’ mission is to impact the lives of the world’s one billion adult smokers by eliminating combustible cigarettes. We have the opportunity to address one of the world’s most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent.
We are a diverse team that is united by this common purpose and we are hiring the world’s best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career at one of the fastest growing companies is compelling, read on for more details.
ROLE AND RESPONSIBILITIES:
- Conduct Supplier Audits through the review of manufacturing processes and records to ensure supplier capabilities meet current and future strategic growth requirements including regulatory, business and Quality Management System requirements
- Assist in developing and monitoring a global supplier control program that ensures all assigned suppliers are systematically evaluated and onboarded on approved supplier list
- Evaluate potential future suppliers and support supplier selection process with the cross-functional team
- Review supplier files and ensure that documents are sufficient for vendor qualifications and oversight and review and approve supplier questionnaires
- Lead and participates in the evaluation and development of Supplier Agreements with suppliers
- Lead assessment of supplier changes and internal/external requests for critical system changes, support and lead quality issues with suppliers & partner with Internal Customers
- Follow up non-conformances identified during supplier audits and identify/drive root cause analysis, corrective action and preventive action implementation
- Monitor supplier quality performance metrics including incoming failures, manufacturing yield and supplier responsiveness, create supplier scorecard and provide necessary supplier feedback to drive supplier performance improvement and report to JUUL management
- Establish & maintain supplier quality procedures in adherence with global policies & guidelines, ensuring efficient continuous monitoring systems are in place
- Facilitate, lead, and collaborate with cross functional teams (manufacturing and operations management) for compliant resolutions to nonconformances
- Support regulatory inspections and internal audits, act as QA representative (SME) for functional area relevant topics
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- Minimum 3 years of experience in a pharmaceutical, medical and/or combination product production environment.
- Thorough knowledge of Quality Management Systems, FDA 21 CFR 210/211/820/ and Part 11, ICH Q7, ISO 13485, ISO 9001, ISO 17025 and applicable international regulations and guidelines governing pharmaceutical and medical devices
- Experience conducting supplier audits and internal audits required
- Experienced in supplier oversight and risk assessments preferred
- Excellent written and verbal communication skills
- Demonstrated collaboration, negotiation, and conflict resolution skills
- Strong working knowledge of DMAIC\Six Sigma problem solving process
- Strong process improvement mindset with excellent project management skills, a strategic business perspective, and critical thinking capability
- Proven ability to lead with integrity and respect, champion change, and execute strategies to meet goals and deliver quality results
- Excellent time management and organization skills, with emphasized attention to detail
- Candidate must be able to work autonomously and independently.
- ASQ certification preferred (i.e. CQE, CQA, Lead Auditor)
- Ability to travel up 35-50% of the time (domestic and international)
EDUCATION: Bachelor's degree required, Master's degree in engineering or science discipline is preferred.
JUUL LABS PERKS & BENEFITS:
- A place to grow your career. We’ll help you set big goals - and exceed them
- People. Work with talented, committed and supportive teammates
- Equity and performance bonuses. Every employee is a stakeholder in our success
- Boundless snacks and drinks
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Excellent medical, dental and vision benefits
JUUL Labs is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees and job applicants, without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. JUUL Labs also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for JUUL Labs in the US.
Back to top