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Post Market Quality Operations Manager
Company | Juul Labs |
Address | , San Francisco, Ca |
Employment type | |
Salary | |
Expires | 2023-06-28 |
Posted at | 10 months ago |
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:
- Help ensure accurate department and process procedures and work instructions are maintained
- 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
- Direct leadership and oversight of the Field Corrective Action (FCA) process
- Maintain knowledge of current global regulations impacting Post Market Surveillance activities
- 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
- Aid in development, maintenance, and communication of key performance indicators for Post Market Surveillance, ensuring that the KPIs are within the required scope
- Develop a team culture of continuous improvement and teamwork that strives to improve quality
- 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
- Lead and support corrective action, process, policy, and continuous improvement projects
- Timely communication of business-related issues or opportunities to the next management level
- Subject Matter Expert (SME) in regulatory audits, internal audits, and inspections as appropriate to represent and defend the Post-Market Surveillance plan
- Additional responsibilities may be assigned
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 3+ years of Quality Management Systems (QMS) Experience
- Demonstrated ability to understand and follow complex written procedures
- Demonstrated ability to influence and drive change
- Knowledge of general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices
- American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is preferred
- Critical thinking and investigation skills
- Demonstrated understanding of FDA 21 CFR Part 820, ISO Standards, EU MDR and Tobacco regulations
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- 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.
- Well organized and able to take on multiple initiatives in an ambiguous environment
- Experience leading QMS projects ideally for medical device/pharma
EDUCATION:
- Bachelor's degree in Engineering, Technology, Science related field
JUUL LABS PERKS & BENEFITS:
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Equity and performance bonuses. Every employee is a stakeholder in our success
- A place to grow your career. We'll help you set big goals - and exceed them
- Excellent medical, dental and vision benefits
- People. Work with talented, committed and supportive teammates
#LI-REMOTE
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:
Tier 2 Range:
Tier 3 Range:
Tier 4 Range:
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