Principal Product Complaint Analyst

Boston ScientificValencia, CA
34d$103,700 - $197,000Hybrid

About The Position

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. About the role: Everyone at Boston Scientific works toward one goal: transforming lives by addressing the most critical challenges in the medical device industry. Patient Care is at the heart of everything we do, and ensuring quality, compliance, and positive outcomes is essential to delivering on that commitment. As a Principal Product Analyst, you will lead strategic initiatives that enhance product quality and performance across global markets. You'll collaborate with a high-performing, cross-functional team to solve complex challenges, applying data-driven insights to identify risks, improve processes, and drive decisions that make a lasting impact on healthcare worldwide. This role offers the opportunity to contribute to meaningful change as part of a team that thrives on shared success. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Requirements

  • Bachelor's degree, preferably in a scientific or technical discipline.
  • Minimum of 8+ years of medical device industry experience
  • Demonstrated ability to understand, shift and contribute to changing priorities
  • Competency of Microsoft Office Suite (i.e., Word, Xcel, PowerPoint, Visio, etc.),
  • Working knowledge and practical implementation of FDA, ISO, MDD regulations within the medical device industry
  • Demonstrated proficiency in project management
  • Travel approximately <5% of the time

Nice To Haves

  • Corrective Action Preventative Action (CAPA) experience.
  • Strong research, communication and presentation skills
  • Effective written and oral communication, technical writing, and editing skills
  • Ability to work independently with minimal direction or supervision
  • SAS, Snowflake or similar querying/analytic software experience

Responsibilities

  • Consistent, positive influence on the culture of the team, setting an example as a leader of high-quality work, effective communication, dealing with adversity, and solution-oriented thinking.
  • Understanding and ensuring compliance to US & OUS regulatory requirements for medical devices for complaint handling and regulatory reporting
  • Participating in the Global Quality Community to lead large, highly impactful projects to improve post market quality across multiple divisions.
  • Utilizing data and analytics to identify areas of risk, opportunities and priorities
  • Coordinating parallel tasks and meetings to drive collaboration of multi-site and multi-functional stakeholders to support project deliverables and timelines
  • Providing and presenting succinct, clear communication to senior leadership on deliverables, timelines and milestones
  • Influence change and align stakeholders to make decisions with limited information
  • Supporting and implementing new Standard Operating Procedures and Work Instructions to improve and/or standardize complaint and regulatory reporting processes
  • Apply systems-thinking to a complex quality system to streamline and identify areas for improvement and identify areas of risk and provide and manage plans for improvement.
  • Providing audit support in the frontroom and backroom
  • Effectively identifying and escalating risks, respectfully challenging management and status quo where appropriate, providing recommendations and working to resolve issues
  • Working independently across the organization
  • In all actions, demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Traveling as required

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Industry

Merchant Wholesalers, Durable Goods

Number of Employees

5,001-10,000 employees

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