דרושים Clinical Quality Assurance Manager ב-Boston Scientific ב-United States, Marlborough

Spencer Gregory Hale

Your responsibilities include:

Sustaining Engineering:

• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
• Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Manages sustaining quality issues, process change impacts, and design change implementations in the BSC Quality System.
• Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
• Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
• Investigates complaints and manages NCEPs at OEM suppliers where the issue is manufacturing-related.
• Supports Supplier Change Impact Assessments for process changes at suppliers.
• Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
• Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.

New Product Development:

• Execute SFMD Plan deliverables for onboarding of products into BSC’s Quality System.
• Support the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.

Quality System Champion:

• Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
• Identifies and advises management on potential improvements to quality systems and processes in the company.
• Champions 100% compliance to company policies and SOP’s.

What we’re looking for in you:
Minimal Qualifications:

• BS degree in engineering or technical field with minimum of 2 years of relevant experience in quality engineering.
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA, SCAR.
• Organized and self-driven.
• Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
• Domestic and international travel up to 25%.

Preferred Qualifications:

• 3+ years of medical device engineering experience preferred.
• Medical Device Industry experience
• Problem Solving and Project Management experience
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems experience (ISO 13485 or similar).
• ASQ certification (CQE, CBA, SSGB, SSBB) desired.

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.

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.

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.

About the role:

Reporting to the Senior Director of MedSurg IT, you will:

• Serve as the primary IT business partner for the Endoscopy division, owning its digital roadmap and aligning technology with business goals.
• Lead enterprise data and AI enablement across both Urology and Endoscopy, scaling data strategies, cloud solutions (AWS, Azure), and governance frameworks and AI initiatives that improve operational efficiency and customer experience.

Digital Strategy & Business Partnership:

• Provide strategic IT leadership for Endoscopy, with ownership of digital roadmap and business alignment
• Act as primary technology business partner between enterprise platform teams and business divisions
• Partner with cross-functional stakeholders to scale digital solutions focused that drive commercial impact and operational excellence
• Translate business requirements into technology strategies and implementation roadmaps
  

Data & AI Strategy & Enablement:

• Lead development and execution of comprehensive data and AI strategies across Urology and Endoscopy divisions
• Partner with enterprise data and AI teams to drive standards and best practices in data governance, quality, and responsible AI adoption
• Champion a data-and AI-driven culture and lead analytics maturity initiatives across business units
• Support implementation of strategic data initiatives that accelerate business programs and decision-making
  

Stakeholder Management & Influence:

• Build and maintain strong relationships with business leaders, serving as trusted technology advisor
• Facilitate alignment between business stakeholders and technology teams on strategic initiatives
• Drive consensus and adoption of digital solutions through effective communication and change management
• Present to and engage senior leadership across all organizational levels on technology strategy and outcomes
  

Program Delivery & Governance:

• Oversee delivery and value measurement of IT programs supporting MedSurg strategic objectives
• Establish scalable processes, frameworks, and governance for digital program execution
• Define and track key performance metrics (KPIs, ROI) to measure value delivery and optimize portfolios
• Ensure programs comply with regulatory, privacy, and security standards
• Monitor and communicate program status, risks, and business value to stakeholders
  

Team & Vendor Management:

• Lead cross-functional project teams, including internal staff and external partners
• Manage vendor relationships, contracts, and service-level agreements for technology solutions
• Mentor and develop talent to build digital capabilities within the organization
• Foster collaborative partnerships across IT and business teams
  

Required qualifications:

• Bachelor’s degree in IT, Computer Science, Engineering, Business, or related field
• 8+ years of IT leadership with people management, cross-functional delivery, and measurable business outcomes
• Proven ability to partner with business leaders and manage stakeholders across all organizational levels
• Experience scaling data-enabled initiatives across multiple business units in complex, matrixed organizations
• Success in developing and operationalizing enterprise data strategies, governance frameworks, and technology roadmaps aligned to business objectives
• Hands-on expertise in data architecture, cloud platforms (AWS or Azure), and modern digital ecosystems
• Exceptional communication and presentation skills for engaging diverse stakeholders and senior leadership
  

Preferred qualifications:

• Proven ability to collaborate with sales and other customer-facing teams to align IT solutions with business objectives
• Healthcare, medical technology, or regulated industry experience
• Background in change management and organizational transformation initiatives

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.

About the Role:

This role will partner closely with ato ensure successful execution of key initiatives while providing the strategic oversight, governance, and cross-functional alignment needed to drive results.

Your Responsibilities will Include

• Partner and collaborate across functions (e.g., IT, Customer Care), divisions, and regions to align strategy, priorities, and roadmaps
• Own and evolve the Digital Commerce playbook, governance model, and SOPs for onboarding divisions and regions, enabling global scalability and consistency
• Develop and manage program-level plans, timelines, budgets, roles/responsibilities, communication plans, and program documentation (newsletters, SharePoint sites, wikis, etc.)
• Partner with the Project Manager to ensure project execution aligns with program-level goals and governance standards
• Identify risks and develop mitigation strategies to ensure delivery of expected results across strategic programs
• Provide updates to management and stakeholders on progress through regular and ad hoc communications
• Develop and deliver program awareness, best practices, and recommendations to management and stakeholders
• Stay current with industry best practices in program and project management by participating in external organizations, conferences, and seminars

Required Qualifications

• BS or MS degree in a related discipline
• 5+ years of relevant experience
• Experience working in large, complex enterprise environments
• Demonstrated experience running projects within an agile framework and methodology
• Strong communication skills—both written and verbal—with the ability to influence at all levels of the organization
• Strong analytical and problem-solving skills
• Proven experience working in a regulated environment with quality systems, including strong documentation skills
• Self-motivated, adaptable, and comfortable operating in a dynamic environment

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.

Spencer Gregory Hale

Sustaining Engineering:

• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
• Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Manages sustaining quality issues, process change impacts, and design change implementations in the BSC Quality System.
• Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
• Investigates complaints and manages NCEPs at OEM suppliers where the issue is manufacturing related.
• Lead investigations into supplier-related nonconformances and implement effective Corrective and preventive actions (CAPA)
• Provide manufacturing support at external vendors by addressing manufacturing process defects and implementing process improvements utilizing Quality System tools.

New Product Development:

• Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
• Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
• Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.
• Review and approve Supplier documentation including validation protocols (IQ/OQ/PQ) , FMEAs, control plans and inspection methods.

Quality System Champion:

• Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
• Identifies and advises management on potential improvements to quality systems and processes in the company.

• Champions 100% compliance to company policies and SOP’s.

What we’re looking for in you:

Minimal Qualifications:

• BS degree in engineering or technical field with minimum of 5 years of relevant experience in supplier engineering, supplier management, or supplier quality engineering.
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Experience with capital equipment or electronics including product development, servicing, and repair.
• Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA, SCAR.
• Ability to work independently; organized and self-driven.
• Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
• Domestic and international travel up to 25%. Note: COVID-19 precautions currently restrict travel. At Boston Scientific, our priority is to protect and aid the health and safety of our employees, our physician customers, and their patients.

Preferred Qualifications:

• 7+ years of medical device engineering experience preferred.
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems experience (ISO 13485 or similar).
• ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired.

Maximum Salary: $ 164500

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.

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 this role:

As a Senior Clinical Evaluation Scientist, you will develop clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports, as well as summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs.

Your responsibilities will include:

• Apply analytical and methodical clinical evaluation approaches to develop benefit-risk profiles for Boston Scientific’s interventional cardiology devices.
• Author and maintain clinical documentation including CERs, PMCF reports, and SSCPs in alignment with regulatory standards.
• Collaborate cross-functionally to ensure clinical content supports product approvals, indication expansions, claims, and post-market requirements.
• Interpret and synthesize data from multiple sources to produce high-quality, compliant clinical evaluations.
• Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data. Includes development of literature search strategies and methodical evaluation of medical literature.
• Create analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategy to address gaps.
• Collaborate with leadership and cross-functional partners to ensure alignment of clinical data with risk documentation, and to contribute to product labeling.
• Aid in the development and execution of strategies for regulatory responses for regulatory submissions

Required qualifications:

• Minimum bachelor’s degree and 4 years of medical writing experience
• Analytical skills, including strong familiarity with medical literature
• Proven experience writing clinical evaluation reports
• Proven experience applying principles of EU MDR

Preferred qualifications:

• Preferred medical device industry experience or knowledge of interventional cardiology and related disease states
• Proven and demonstrated ability to understand engineering documentation, including risk documentation
• Proven experience with regulatory body communications

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.

About the role:

This role reports to the FinOps Associate Director Lead and requires limited travel as needed for team coordination or stakeholder meetings. The position could be located in multiple BSC locations.

Key responsibilities include:

• Lead the GSC FinOps standardized reporting function, including mentoring a global team of Reporting and BI Analysts; provide coaching, guidance, and performance development
• Partner with Finance Forward and Global HQ FinOps teams on standing up the new capability
• Set longer term strategic roadmap for maturation of GSC finance reporting needs
• Develop and oversee reporting templates, KPIs, governance model, and reporting cadence
• Partner with all stakeholders including plant controllers and IT to ensure reporting meets evolving business needs
• Design and implement dashboards that enable self-service access to key financial metrics
• Oversee the transition of reporting responsibilities from site-level teams into the FinOps team, including process discovery, documentation, and stakeholder alignment
• Develop, document, and maintain SOPs, control frameworks, and audit compliance for FinOps-owned reports
• Define and track performance KPIs for the reporting function; drive continuous improvement initiatives

Required Qualifications:

• Bachelor’s degree in Accounting, Finance, Data Analytics or a related field
• 6+ years of experience in reporting, finance, supply chain analytics, or FP&A roles, preferably within manufacturing, medical device, or pharmaceutical industries
• Minimum 3 years in a leadership role managing teams and cross-functional stakeholders
• Familiarity with shared services or COE models
• Experience in inventory management, cost accounting, and inventory reporting
• Technical knowledge of reporting tools, data architecture, and inventory KPIs
• Proven experience building and scaling inventory or operational reporting in a global environment
• Hands-on experience with ERP systems, BI tools (Power BI, Tableau), and data platforms
• Verbal and written communication skills in both local language and English
• Strong leadership and interpersonal skills to manage a diverse, global team
• Advanced experience with MS power tools such as Power Query, Power Pivot, and Power BI
• Strong project management and change management capabilities

Preferred Qualifications:

• MBA degree preferred
• Experience working in ERP systems and financial data tools like Hyperion
• Experience leading large-scale process discovery, documentation and standardized planning initiatives
• Proven ability to lead process improvement and technology adoption initiatives

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.