Quality Engineer I

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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 This Role:
Responsible for providing technical acumen and leadership to the IC Arden Hills Post Market Complaint Investigation Site (CIS) that directly supports complaint product investigations and signal escalations ranging from Single Use Devices to Capital Equipment and accessories.  The team uses product performance data to investigate Post-Market field performance signals in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety.  Key focus is on understanding and developing product and process specific improvements to increase rate of actionable outcomes of product investigations and improved use of Engineering Essentials and Problem-Solving Analytics to improve product performance in sustaining and future product lines.  Will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level.  Responsible for identifying and implementing continuous improvements to improve product performance and complaint processes.  This role provides significant visibility across site and divisional leadership.  

Your Responsibilities Will Include:

• Analyzing customer complaints, events and other post market surveillance data by examining the data for patterns and trends and investigating when necessary.  
• Conducting product signal escalation analysis, investigation, and quality system documentation to identify performance improvement opportunities.  May include NCEP & CAPA ownership.
• Mentoring product investigators by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques.  Grow team utilization of investigative equipment (X-Ray, FTIR, SEM, etc)
• Partnering with cross-functional teams to ensure the development and execution of streamlined, robust solutions to CIS processes are effectively implemented while still meeting organizational and regulatory requirements.
• Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.
• Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Post Market organizations.  
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• 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.

Required Qualifications

• University degree or the equivalent education with 0-2 years of relevant experience 

Preferred Qualifications

• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards.
• Experience in Medical Device industry 
• Demonstrated effective change leadership and results-oriented focus
• Demonstrated problem-solving & data analysis capabilities 
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
• Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
• Ability to collaborate and influence across multiple, cross-functional teams
• Strong ability to successfully multi-task and adaptability
• Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions.
• Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis
• Self-starter with the ability to identify improvement opportunities.
• Comfort speaking to groups of individuals including divisional senior leaders.  Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.
• Familiarity with Post Market requirements and IT systems
   

Requisition ID: 582057

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.