Associate Manager, Product Surveillance

Merz North America•Racine, WI

18h

About The Position

The Associate Manager, Product Surveillance is responsible for providing tactical and strategic leadership for the Product Surveillance Associates for both technical and safety related complaints. Day-to-day activities include coordination, management and review of Complaints. Perform and/or assist with tasks required to oversee the proper operation and monitoring of Complaints as it pertains to Good Documentation Practices and Local and Global Regulations. Oversee and/or assist with tasks related to the activities associated with operation of Merz North America Inc. Quality System and as directed. Manage the product surveillance staff including interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Requirements

Bachelor's Degree
2+ years: Quality experience in Medical Device, Pharmaceutical and/or equivalent regulated industry
Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
Strong technical and general problem-solving skills; experience with NCR/CAPA processes
Medical and/or scientific terminology
Professional phone etiquette with the ability to appropriately handle sensitive information.
Proficient in Microsoft Office Suite, Adobe, and Quality System Management Software.
Highly organized with strong attention to detail.
Highly effective communication skills including written and verbal.
Proven leadership skills with the ability to manage and direct teams and projects, ensuring successful outcomes and effective collaboration.
Ability to work with company staff and communicate effectively throughout the organization.
Strong time management skills with proven ability to prioritize and manage multiple records/reports simultaneously.

Nice To Haves

Experience with post market surveillance and complaint handling.
Supervisor or Lead Experience

Responsibilities

Support team by acting as a stream lead for all aspects of the complaint process.
Coordinate with Global Product Safety to evaluate and investigate patient-related complaints.
Document consistent and compliant safety and reporting assessments.
Lead post market initiatives including compiling and assessing data for PSUR and other reports.
Lead risk management activities including review and coordination of post market data.
Review, approve, and close complaints in accordance with applicable SOP(s).
Manage the training program by developing, coordinating, and delivering training.
Maintain and update departmental metrics and reporting.
Conduct statistical analysis of complaint trends, make conclusions, and drive actions including 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.
Develop solutions to a variety of complex problems and identify corrective actions.
Proactively identify and implement operational changes to improve efficiencies in all aspects of complaint handling.
Drive continuous improvement initiatives / projects in Product Surveillance as well as items that arise as a result of complaint data.
Support/Conduct investigations associated with product deviations, product non-conformances, CAPAs, scrap, and rework.
Analyze the data for the reasons of Quality Improvement and reporting.
Originate, review, and approve internal operating procedures and specifications through the Document Change process.
Support/Lead the development, verification, and validation of product changes and the introduction of new products as it relates to post market surveillance.
Lead internal quality system audits.
Support and participate in external quality system audits.
Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.
Submit MDRs and Vigilance Reports according to regulatory timelines.
Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting.
Articulate a clear and compelling vision aligned with the global cultural tenets and strategic objectives of the company.
Clearly define roles and responsibilities while holding members accountable for their performance.
Develop talent and skills of individual team members.
Empower leaders and employees to make informed decisions, enabling autonomy while providing guidance and support.