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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 |
THE COMPANY:
- 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
- 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
- Bachelor’s degree in Engineering, Technology, Science related field
- 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
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