Associate Director/Director, Global Product Surveillance - #260065
Merz Aesthetics
Date: 11 hours ago
City: Racine, WI
Contract type: Full time
Keys Responsibilities
Global Strategy & Program:
Global Strategy & Program:
- Establish and maintain global strategy and program for Product Surveillance.
- Lead product surveillance team ensuring that appropriate processes are established and followed. Responsible for ensuring records are timely and accurate.
- Establish and maintain departmental metrics and reporting. Support implementation of product updates or changes based on Complaint data.
- Serve as the point of escalation and Quality Business Partner for commercial and customer relationships related to the complaint handling process.
- Provides strategic direction to internal and external partners regarding integration of Post Market Processes into Design and Change Control systems
- Development of highly competent staff and future leadership.
- Engagement with senior/executive leadership including knowledge transfer and strategic guidance, including communication regarding most current trends and data analysis regarding product surveillance.
- Allocates human resources and selects, acquires, and deploys appropriate methodologies to fulfill near term goals and commitments while ensuring sustainable quality performance.
- Motivates and leads their organization to achieve business objectives.
- Evaluate and Implement New Technologies and Improve Operational Efficiencies.
- Secure firm knowledge of business processes, global regulatory requirements and support on-going system use and training of users.
- Actively identify and execute process improvements in alignment with global stakeholders.
- Research and identify enabling solutions, best practices, and technologies to proactively address customer needs and regulatory requirements.
- Continuously evaluate policies, procedures, and training to ensure continued compliance with company standards, current industry best practices and current regulatory requirements.
- Leads effective complaint management by ensuring appropriate complaint investigations are conducted and effective trending is utilized to ensure safety and effectiveness of Merz products.
- Trends data and monitors trends for possible systemic issues that may be impacting one or more products and assigns appropriate corrective actions internal and external stakeholders to mitigate issues.
- Reviews recommended CAPAs, as part of complaint closure process, and determines their appropriateness for the Root Cause(s) that were identified.
- Assign tasks to team members to ensure appropriate issue escalation occurs related to any quality or compliance issues.
- Manages the implementation of any revisions or new implementation of new Enterprise Quality Management Systems for Complaint Handling and Adverse Event Reporting.
- Support continued company certification to the appropriate Quality Management System Standards and Regulations and assist with all related audits and inspections as required.
- Maintain positive working relationships and ensure appropriate representatives from affected departments are involved.
- Manage Departmental Budgets in accordance with approved targets
- Bachelor's Degree. Required
- 10(AD)/ 15 (D) years minimum in Pharmaceutical or Medical Device Industry. Required
- Proven leadership in managing cross-functional teams and driving product quality improvements. Required
- Master's Degree. Preferred
- 2 (AD) 5(D) years minimum in a leadership role. Preferred
- In-depth understanding of medical device regulations: FDA 21 CFR Part 820, Part 803, ISO 13485:2016, EU MDR, and Canadian MDR. Required
- Engineering principles and methodologies related to product design, manufacturing, and post-market surveillance. Required
- Quality management systems and risk assessments. Required
- Industry trends and advancements in medical device technology. Required
- Strong analytical, Statistical, technical and general problem-solving skills. RequiredAbility to manage priorities in a fast-paced environment. Required Exceptional leadership capabilities to manage and mentor teams. Required
- Ability to work effectively in a global, matrix environment. Required
- Ability to work independently as well as direct and control the efforts of Direct Reports as applicable. Required
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts. Required
- Comprehensive Medical, Dental, and Vision plans
- 20 days of Paid Time Off
- 15 paid holidays
- Paid Sick Leave
- Paid Parental Leave
- 401(k)
- Employee bonuses
- And more!
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