Quality Compliance Fellow jobs at Boston Scientific in United States, Santa Clarita

This is a defined term position with an expected duration of 1 year.

Your responsibilities will include:

• Identifying the opportunities for continuous improvement and initiates activities to support the improvement process.
• Leading quality projects of major magnitude and scope.
• Providing significant guidance and approval regarding technical strategies and approaches.
• Managing and providing direction to quality engineers on professional, personnel issues, and provides development opportunities.
• Providing guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff.
• Participating on team projects and assignments, facilitating or leading teams as necessary.
• Determining project staff assignments and schedules work to meet completion dates and deliverables.
• Working cross-functionally in identifying and resolving technical issues.
• Driving and evaluates project and department progress and results.
• Providing guidance and decisions on Operations and Design Control activities to ensure continued compliance with internal BSC procedures, and applicable regulatory and international standards as defined in the BSC Quality Policy and site Compliance Matrix.

Required qualifications:

• Bachelor degree
• Minimum of 7 years experience in medical device or similar regulated industry
• Minimumof 4 years leading cross functional teams in a technical field
• Able to travel 1-2 times a year

Preferred qualifications:

• More than 10 year of experience in Medical Devices or similar regulated industry
• Higher education MBA, MS in science or engineering
• Neuromodulation device experience, capital equipment experience
• Experience working with TUV, BSI, FDA etc
• Boston Scientific experience

Maximum Salary: $ 243000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

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

About the role:The Software Quality Assurance Engineer III will serve as a Quality representative in the Neuromodulation Software/Firmware product development. The Software Quality Assurance Engineer III will provide Quality Engineering input throughout the product life cycle process. The Software Quality Assurance Engineer III will be actively participating in design activities of new product development and sustaining activities for commercialized product. The Software Quality Assurance Engineer III will be involved in the development, testing and validation of Software/Firmware products.

In the Neuromodulation division, we continue to advance science in electronic implantable technologies that help patients manage debilitating chronic pain and neurological conditions such as movement disorders.

Your responsibilities will include:

• Actively working within a team of Product Software Quality Assurance Engineers.
• Actively contributing to all aspects of Software/Firmware Quality Assurance activities in a highly regulated Active Implantable Medical Device environment.
• Ensures the Quality of software systems, validate product software and firmware requirements, security requirements and compliances.
• Support design, development, and test of software related to all Boston Scientific Neuromodulation product lines during their entire development life cycle, from requirements gathering phase to the retirement phase.
• Support the creation and execution of Design Validation Plan, Protocols and Reports to perform System level testing of Neuromodulation products and report any issues discovered.
• Perform review of design, development, and testing of software and firmware used in Boston Scientific Neuromodulation product lines.
• Perform review and approval of documentation associated with user requirements, hazard analysis, security risk assessment, usability, functional and design specifications, design reviews, test protocols, requirements traceability, etc.
• Actively working to support Automated Test Equipment validation activities.
• Actively working to support Software related CAPA.
• Support Design Validation activities, which encompass reviews of User Needs Requirements, Design Requirements, Functional, Architectural, Module Design Details, Code and Design reviews, Unit tests, Integration tests, System level (black box), Structural (white box), Test Automation, Ad-Hoc/Exploratory test activities, Cybersecurity, Usability, and Risk Management, Design FMEAs, and Hazard Analysis.
  

Required qualifications:

• Bachelor's degree in Software/Electrical Engineering/Biomedical Engineering
• 4+ years of working experience in software engineering and/or testing
• 2+ years experience in Programming Languages such as C#, C++, Swift, Node.js, Java/JavaScript, Cloud, Windows, iOS, Android, Python, LabView
• Manual system level testing experience
• Understanding of Software Development Life Cycle Processes per IEC 62304

Preferred qualifications:

• Master's degree in Computer Science or Software/Electrical Engineering
• Must be team-oriented with people skills and positive can-do attitude in dealing with many customers, and several competing tasks from various departments (R&D, Marketing, Manufacturing, Quality and Regulatory, Clinical, Project Management, etc.)
• Must be detail oriented and have a passion to “Build Quality In” the products
• Experience working in the medical device industry or other highly regulated environment
• Basic academic knowledge of principles of Neuromodulation
• Some experience with CAPA, Complaint Handling and External Audit
• Experience/Understanding of Risk Management as per ISO 14971
• Understand Premarket Cybersecurity Guidance, Post Market Cybersecurity Guidance and 81001-5-1
• Understand Bluetooth technology
• Understand Mobile applications development
• Understand aspects of HIPAA and GDPR compliance practices
• ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE)

Maximum Salary: $ 151400

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

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

Solution Promotion and Sales:

• In collaboration with Divisional teams:

• Develop and implement go-to-market strategies for Capital Equipment remote connectivity solutions, with a strong emphasis on field-based customer engagement and solution selling.
• Define value proposition and pricing strategy for Software as a Service (SaaS) and Data as a Service (DaaS) offering. Align with Service Contract strategy.
• Engage directly with divisions and customers in the field to seek feedback and input on the value of the solution, promote and demonstrate the value, and drive usage and adoption.
• Identify and target potential customer segments, offering tailored solutions that meet their unique needs and enhance operational efficiencies.

Product Marketing and Brand Alignment:

• Craft a cohesive brand narrative for remote connectivity, ensuring that messaging aligns with company objectives and resonates with customers across diverse healthcare settings.
• Collaborate with product, regulatory, and divisional marketing and sales teams to deliver clear, compliant messaging that addresses customer pain points and highlights the solution’s benefits.

Customer Engagement and Training:

• Work with Divisions to support:

• Customer onboarding and training related to remote connectivity solutions.
• Development of customer-facing resources, presentations, and training materials to enhance understanding and promote adoption.
• Collection and analysis of customer feedback to continually improve the product and customer experience.

Cross-Functional Collaboration:

• Work closely with IT, Biomed, legal, and other relevant departments to address cybersecurity and legal challenges associated with remote connectivity.
• Coordinate with customer-facing and technical support teams to ensure seamless integration and adoption of connectivity solutions within healthcare environments.

Regulatory and Compliance:

• Partner with divisional Regulatory and Compliance teams to ensure that all marketing and sales efforts meet industry standards, particularly for Class II and Class III medical devices.
• Partner with divisional Regulatory and Compliance teams to address cybersecurity and legal considerations in solution messaging, reassuring customers of data safety and regulatory compliance

Required qualifications:

• 7+ years of experience in product marketing, solution selling, or customer success management within the digital health, medical device, or healthcare IoT industry.
• Proven cross-functional collaboration skills, with demonstrated experience addressing legal, cybersecurity, and compliance requirements for connected medical solutions.
• Sales and field engagement experience with a focus on driving solution adoption through direct customer interaction and fieldwork.
• Technical and regulatory knowledge related to Class II and Class III medical devices, including familiarity with cybersecurity protocols and compliance standards.
• Excellent communication skills, both written and verbal, with the ability to present complex technical information clearly and persuasively to various audiences, from clinical staff to IT professionals.
• Bachelor’s degree in marketing, Business, Biomedical Engineering, or a related field (advanced degree preferred)

Preferred qualifications:

• Master’s degree in marketing, Business Administration, Biomedical Engineering, or a related field.
• Experience in digital health or IoT product management, especially with healthcare connectivity solutions.
• Project management skills, with the ability to manage multiple projects simultaneously and deliver results in a dynamic environment.
• Customer-centric mindset with a strong orientation toward customer satisfaction and successful product adoption.

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

The Design Quality Assurance Fellow will develop, establish and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional quality goals and priorities. Serves as a liaison for development teams to support compliance related project goals. Collaborates with Quality management to recommend, design and implement functional process improvements and guidance on compliance related matters. May mentor less experienced Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate.Your responsibilities will include:

• Supports Quality System PIR and Field Action sub-process through managing and supporting the PIR/FA process
• Maintains collaborative relationship with Regulatory Agencies, specifically FDA.
• May author, executes, and will supports all aspects of Field Action documentation working closely with Post Market Communication team, regulatory and Field Actions teams.
• Identifies, develops, establishes, maintains, and improves quality systems methodologies, systems, and practices which meet company and regulatory requirements.
• Serves as an expert-level Quality representative to improve awareness, visibility, and communication on quality system initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
• Provides focused quality systems compliance expertise within product development, operational, or system/services support.
• Advanced-level aptitude in interpreting and applying external quality system management regulations and standards.
• Provides project direction, coaching, and mentoring for quality system personnel at all levels of the organization.
• Bridge the gap on the Global vs local Quality System documentation by proactive review and assessment.
• Drives improvement within the organization as well as global level improvement and changes to support QMS, CAPA, PIR etc
• Supports the development team on strategy and compliance around, new product development, sustaining and HFA (Human Feasibility Assessment studies.
• Supports the organization by combing the business needs with compliance and setting the right strategy for success.
• Assesses local and global processes and establishes the most efficient path to drive the organization forward.
• Works as a liaison between Med Safety and PIR team, by working with the CIS team to drive data as needed to support complex CAPAs or PIR activities
• Works with CAPA team to support and drive risk evaluations and updates
• Is responsible for CAPA sign off for all CAPA resulting from PIRs

Required qualifications:

• Bachelor’s of science degree
• Minimum of 10 years relevant experience, preferably in medical device industry
• Comprehensive working knowledge, interpretation and application of all regulations and standards listed in the BSC Global Policy Quality System Management:  21 CFR Part 820, ISO 13485, AIMDD, MDD, MHLW, MDR SOR/98-282, 21 CFR Part 211, ISO 14971

Preferred qualifications:

• Master’s degree and 7+ years relevant experience, preferably in medical device industry or other regulated industry
• Experience working on PIRs or evaluations supporting field action decisions
• Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements
• Excellent verbal / written communication, interpersonal, project management, and organizational skills; must be able to multi-task, and analyze information quickly
• Ability to communicate with all levels of the organization
• Must be able to work independently, lead and / or participate as part of a team
• Must be proactive, work independently, and be a contributing member of a highly visible team
• Must have working knowledge of Medical device product development cycle
• Must have experience working on NCEPs, CAPAs and Field Actions
• Prior experience working on Class III medical device projects
• Prior experience working on HFA (Human Feasibility Assessment) projects
• Prior experience leading teams on complex CAPAs
• Prior experience interfacing with auditors or investigators directly, supporting Quality System audits
• Design Quality experience

Maximum Salary: $ 243000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

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

Your responsibilities include:

• Provide Quality Engineering support for sustaining activities and improvement projects for commercial products, with a focus on the project of process relocations within BSC sites.
• Support Non-Conformance Event Prevention (NCEP) and Correction and Preventive Actions (CAPA) activities that include, but not limited to, containment tasks, risk analysis, problem-solving, cause investigations, and written documentation of activities.
• Investigate complaint data, reports, and trends that support projects, issues, and performance of products.
• Participated in project team meetings, contribute to the discussions with questions/feedback, and collaborated with team members to accomplish required project deliverables.
• Review and approve document deliverables in the document approval system. Provide feedback and proposed updates as needed to ensure clear, compliant information.
• Understand, support, and/or drive change assessment strategies.
• Monitor and track the progress of quality-related tasks and initiatives. Collaborate and follow up with team members to ensure completion of assigned tasks within established timelines.
• Communicate across functions and levels to ensure stakeholders are informed and aware of project status, issues, roadblocks, etc.

What we’re looking for in you:

Required Qualifications

• BS/BA Degree in engineering, or a related field.
• 2+ years of experience in quality engineering or related engineering discipline
• Proficiency in basic Microsoft Office applications (Word, Excel, PowerPoint, Project, Visio)
• Ability to travel up to 10% as needed

Preferred Qualifications

• 2+ years of experience in the medical device industry with an understanding of Quality System Requirements
• Strong technical writing skills and ability to clearly communicate complex information
• Ability to effectively and efficiently collaborate within cross-functional teams
• Problem solving experience with nonconformances and/or corrective actions
• Project/task management experience
  

Maximum Salary: $ 138300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

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