Senior Supplier Auditor

  • JUUL Labs
  • Suzhou, Jiangsu, China
  • Sep 10, 2019
Quality & Regulatory Affairs

Job Description

THE COMPANY:

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 vapor product. 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, CPG 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.

 

ROLE AND RESPONSIBILITIES:

JUUL Labs is searching for a Senior Supplier Auditor to join our Quality Supply Chain team in China. In line with our company expectations, this role is critical to ensure that our suppliers operate to the correct standards which allow us to manufacture products meeting their defined specifications which will enable us to bring high quality products safely and reliably while meeting regulatory compliance. This will be accomplished through analytical and objective evaluation of facility policies, practices, and observations.

  • Coordinate with the suppliers for audit dates, participants, audit agenda and pre-review documentation.
  • Conduct supplier audits, seeking conformity to applicable JUUL Labs requirements and external standards; by interviewing relevant personnel, making observations and inspections and reviewing relevant records and documentation.
  • As necessary, liaise with team members to determine validity of audit findings.
  • Conduct reviews and perform audits resulting in documentation and communication in English of findings and identification of risk across large and complex medical device businesses.
  • Prepare and submit audit reports for review and approval within due date according to JUUL Labs procedures.
  • Ensure timeliness, consistency and accuracy in all supplier audits and audit reports.
  • Work with suppliers to ensure correction, corrective actions and preventive actions resulting from audit findings are initiated, implemented and closed in a timely manner.
  • Maintain audit report, audit finding files and update related tracker according to procedures established by JUUL Labs.
  • Provide training for suppliers on GMP, ISO13485, CAPA, EHS, regulatory requirements, and Juul expectations.
  • Collaborate with global procurement and site SQE team as needed for supplier audit findings and audit schedule.
  • Follow and adhere to all required protocols and procedures of the certification bodies, scheme standards, and accreditation bodies.
  • Maintain applicable professional development and training required for audit proficiency.
  • Take prompt action to prevent, mitigate, or remedy any legal, ethical, policy, or code of conduct violation or potential violation and provide a detailed and objective report on any issues to manager immediately.
  • Responsible for ensuring all policies and procedures are in compliance with applicable FDA, state, OSHA, and ISO regulations and standards. Relies on experience and judgment to plan and accomplish goals.
  • Participate in supplier pre-assessment, supplier evaluation, and supplier monitoring as required.
  • Participate in regulatory and accreditation audits and inspections as needed.
  • Other supplier quality program responsibilities as assigned. 
  • Domestic and international travel to supplier sites, up to 60% of the time

 

PERSONAL AND PROFESSIONAL QUALIFICATIONS:

  • 5+ years of experience as a Quality Auditor in a regulated Medical Device environment, with a minimum of 50 audits performed in a Lead Auditor role
  • Strong Knowledge of ISO13485, ISO14971, ISO14001, ISO45001 and 21 CFR 210, 211, & 820
  • Lead Auditor certification (ASQ CQA/Exemplar Global) preferred
  • Strong auditing experience in medical device and/or contract manufacturing required
  • Experience with Risk Assessments
  • Excellent analytical and investigation skills
  • Excellent attention to detail, sound judgment, and ability to work independently under pressure
  • Ability to prioritize tasks and deliver assignments with high quality in a timely manner
  • Excellent interpersonal skills, ethical, able to interact with all levels of people from production worker to management
  • Strong verbal and written communication skills. Fluent in writing English

 

EDUCATION:  Bachelor’s degree in Science or Engineering from an accredited university 

 

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
  • Performance bonuses. Every employee is a stakeholder in our success
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