Manager, Global Vigilance Writing (Hybrid - Acton, MA)

Insulet Corporation•Acton, MA

1d•$112,300 - $168,400•Hybrid

About The Position

The Manager, Global Vigilance Writing is a hands-on technical leader serving as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives supporting post-market vigilance. This role will provide direction to individuals who are responsible for the assessment, follow-up, coding, and vigilance activities for complaints determined to be reportable for the US FDA and other countries. The role requires strong organization skills and attention to detail while working in cross functional teams to accomplish departmental and company goals. This position is an integral part of Insulet’s Post Market Surveillance Department. It requires leadership, organization, process knowledge, and attention to detail while working with other QA/RA functions to ensure compliance and the accomplishment of departmental and company goals. This position is responsible for the management of a complaint lab team (consisting of Post Market Engineering Team Leads, Failure Analysis Engineers, Associate Failure Analysis engineers, Quality Technicians & Quality Associates) that process all investigations from initiation to closure.

Requirements

BS/BA degree in engineering
Demonstrated people management experience leading teams of 5 or more technical employees.
8+ years of experience in the field with 5 or more years of related experience in medical device complaint processes.
3-5 years of people manager / supervisory experience.
Knowledge of Regulatory and Quality Management skills.
Effective verbal and excellent technical writing skills.
Ability to communicate and work effectively within the organization.
Ability to organize and follow through with tasks with minimal supervision.
Lead individuals in the process compliance needs of the organization.
Excels at generating and maintaining organized and accurate records.
MS Office, strong word processing and spreadsheet skills.
Familiarity with the handling of biohazardous materials.

Nice To Haves

Proven leadership skills to engage, coach, mentor, and develop the team, inspire high quality and timely work.
Demonstrated ability to organize, motivate, empower, and build a cohesive team would be a distinct advantage.

Responsibilities

Monitor complaint lab activity to ensure timely complaint resolution that meets or exceeds departmental, customer and regulatory requirements.
Approve / Sign-off work evaluations from complaint lab team.
Technical expert responsible for providing feedback and training concerning write-ups and approvals to drive team improvement.
Utilize superior leadership to model, reward, and enforce behaviors that support Insulet’s culture.
Supervise, mentor, and provide work direction to the complaint lab team.
Drive performance and establish Key Performance Indicators (KPIs) to achieve organizational goals for complaint rate, daily throughput, and efficient staff utilization.
Works closely with appropriate personnel in R&D, Operations, and Quality Assurance to further analyze investigation results to determine root cause to mitigate and/or eliminate future complaints or customer dissatisfaction.
Promote and instill a culture of continuous improvement through standard improvement principles and practices (i.e. line balancing, value stream mapping, pareto analysis, etc.).
Establish work planning to include development and maintenance of a plan incorporating hiring, training, efficiencies, etc.
Must adhere to all regulatory requirements for complaint handling including the FDA and any other competent authority as required.
Effectively write responses to competent authorities upon their request for more information.
Purchase appropriate consumables for the continued operation of the complaint Lab.
Direct the training efforts on evaluations and procedural changes.
Performs other duties as assigned.