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Post Market Quality Operations Manager

Company

Juul Labs

Address United States
Employment type FULL_TIME
Salary
Category Manufacturing
Expires 2023-05-17
Posted at 11 months ago
Job Description
THE COMPANY:


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:


The Post Market Quality Operations Manager is responsible for driving the progress of complaints with adverse experiences throughout the complaint lifecycle to ensure proper documentation and timely closure of each case. The Post Market Quality Operations Manager will support the operation and maintenance of the Quality Management System as it relates to Post Market Surveillance. The Post Market Quality Operations Manager will manage the Field Corrective Action process and identify continuous improvement opportunities and develop, deploy, and maintain global harmonized processes in compliance to established and evolving regulatory requirements.


KEY RESPONSIBILITIES:


  • Maintain knowledge of current global regulations impacting Post Market Surveillance activities
  • Timely communication of business-related issues or opportunities to the next management level
  • Help ensure accurate department and process procedures and work instructions are maintained
  • Develop a team culture of continuous improvement and teamwork that strives to improve quality
  • Direct leadership and oversight of the Field Corrective Action (FCA) process
  • Aid in development, maintenance, and communication of key performance indicators for Post Market Surveillance, ensuring that the KPIs are within the required scope
  • Ensure compliance to post market surveillance processes for regulatory database searches, literature reviews, surveys, internal filings, and other proactive surveillance requirements or requests
  • Apply knowledge to develop and optimize processes and suggest improvements as needed and/or required
  • Additional responsibilities may be assigned
  • Lead and support corrective action, process, policy, and continuous improvement projects
  • Provide primary support of FCA activities and assist and support the team to ensure that corrections removals and recalls are managed effectively and efficiently and reported to regulatory agencies as required
  • Support complaint database upgrades and conversions by providing input and performing system testing
  • Support inspections by regulatory agencies (e.g., FDA, Notified Bodies) or internal audits as requested
  • Actively seek collaboration and build relationships with internal customers and external partners to improve overall outcomes and timely project completion
  • Subject Matter Expert (SME) in regulatory audits, internal audits, and inspections as appropriate to represent and defend the Post-Market Surveillance plan


PERSONAL AND PROFESSIONAL QUALIFICATIONS:


  • Demonstrated ability to influence and drive change
  • Experience leading QMS projects ideally for medical device/pharma
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Critical thinking and investigation skills
  • 3+ years of Quality Management Systems (QMS) Experience
  • Demonstrated ability to understand and follow complex written procedures
  • Experience with global product complaints including medical information call center processes, complaint handling, consumer safety, adverse events, product sample return, clinical and product investigation process, etc.
  • Demonstrated understanding of FDA 21 CFR Part 820, ISO Standards, EU MDR and Tobacco regulations
  • American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is preferred
  • Well organized and able to take on multiple initiatives in an ambiguous environment
  • Knowledge of general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices


EDUCATION:


  • Bachelor’s degree in Engineering, Technology, Science related field


JUUL LABS PERKS & BENEFITS:


  • Excellent medical, dental and vision benefits
  • Cell phone subsidy, commuter benefits and discounts on JUUL products
  • 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


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.


SALARY RANGES:


Salary varies by role, level and location, and is dependent on the cost of labor in a given


geographic region among other factors. These ranges may be modified at any time.


LOCATIONS:


Tier 1 Locations: Greater New York City, and San Francisco Bay Area


Tier 2 Locations: Greater Boston, Washington DC Metropolitan Area, Seattle/Tacoma,


Greater Sacramento, Los Angeles/OC/San Diego


Tier 3 Locations: Rest of New England, NY Capital District, Rest of New Jersey, Greater


Philadelphia, Pittsburgh, Delaware, Rest of Maryland, Rest of Virginia, North Carolina,


Atlanta, Miami-Fort Lauderdale-WPB, Chicagoland, Dallas, Houston, Austin,


Minneapolis/St. Paul, Colorado, Phoenix, Reno, Las Vegas, Portland Ore./Vancouver


Wash., Rest of California, Hawaii


Tier 4 Locations: Rest of US including Alaska and Puerto Rico


Tier 1 Range:


$110,000—$165,000 USD


Tier 2 Range:


$102,000—$153,000 USD


Tier 3 Range:


$95,000—$143,000 USD


Tier 4 Range:


$87,000—$131,000 USD