דרושים Quality Manager ב-Boston Scientific ב-United States, Carlsbad

About the role:

This position requires a proactive and strategic quality leader who will drive system excellence, continuous improvement, and team development while supporting the company’s mission to deliver safe and effective medical devices.

Your responsibilities will include:

● Lead the development and implementation of quality policies and procedures that ensure compliance with applicable U.S. and international regulatory standards.

● Manage Quality Control functions related to disposable product operations, including receiving inspection, in-process inspection, final inspection, product release, NCR management, clean room monitoring, and supplier quality.

● Oversee metrology and calibration activities.

● Champion initiatives related to quality reporting systems and continuous improvement efforts.

● Identify opportunities for risk reduction and cost improvement while maintaining quality excellence.

● Provide leadership, coaching, mentoring, and development for Quality team members and cross-functional stakeholders.

● Serve as a site advocate for Quality Best Practices and current Good Manufacturing Practices (cGMP).

● Collaborate with engineering teams to develop and maintain Risk Management documentation, including FMEAs and hazard analyses.

● Build and scale the Quality Engineering function for disposable devices in alignment with BSCs growth strategy.

● Contribute to audits and regulatory inspections, providing expert guidance on quality systems.

● Set operational objectives, delegate assignments, and ensure timely completion of work by team members.

● Directly manage departmental activities, including performance, staffing, and budget.

● Ensure full compliance with quality system procedures and regulatory requirements.

● Foster a culture of collaboration, accountability, positivity, and continuous improvement.

● Demonstrate professionalism in all interactions with internal stakeholders and external partners.

Required qualifications:

● Bachelor's or Master's degree or equivalent combination of education and experience.

● Minimum of 15 years' experience in the medical device industry.

● Minimum of 5 years' experience in quality management.

● Experience working in Quality within catheter design and production or a similar medical device environment.

● Demonstrated experience with Design Controls, Risk Analysis, Process and Product Validation, and statistical methods.

● Applied understanding of 21 CFR 820, EN ISO 13485:2016, and ISO 14971:2019.

● Expertise in product sterilization, biocompatibility, and clean room compliance.

● Proven ability to lead through influence, manage sensitive situations, and interact effectively with executive stakeholders.

Preferred qualifications:

● Strong verbal and written communication skills with an ability to generate clear, concise, and timely reports.

● Ability to manage significant workloads, prioritize effectively, and deliver results under pressure.

● High attention to detail, accuracy, and proactive problem-solving skills.

● Strong interpersonal and listening skills, with the ability to adapt to change and build positive working relationships.

● Demonstrated success in creating realistic plans, setting goals, and executing cross-functional initiatives efficiently.

Maximum Salary: $ 197000

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:

This position requires a proactive and strategic quality leader who will drive system excellence, continuous improvement, and team development while supporting the company’s mission to deliver safe and effective medical devices.

Your responsibilities will include:

● Lead the development and implementation of quality policies and procedures that ensure compliance with applicable U.S. and international regulatory standards.

● Manage Quality Control functions related to disposable product operations, including receiving inspection, in-process inspection, final inspection, product release, NCR management, clean room monitoring, and supplier quality.

● Oversee metrology and calibration activities.

● Champion initiatives related to quality reporting systems and continuous improvement efforts.

● Identify opportunities for risk reduction and cost improvement while maintaining quality excellence.

● Provide leadership, coaching, mentoring, and development for Quality team members and cross-functional stakeholders.

● Serve as a site advocate for Quality Best Practices and current Good Manufacturing Practices (cGMP).

● Collaborate with engineering teams to develop and maintain Risk Management documentation, including FMEAs and hazard analyses.

● Build and scale the Quality Engineering function for disposable devices in alignment with BSCs growth strategy.

● Contribute to audits and regulatory inspections, providing expert guidance on quality systems.

● Set operational objectives, delegate assignments, and ensure timely completion of work by team members.

● Directly manage departmental activities, including performance, staffing, and budget.

● Ensure full compliance with quality system procedures and regulatory requirements.

● Foster a culture of collaboration, accountability, positivity, and continuous improvement.

● Demonstrate professionalism in all interactions with internal stakeholders and external partners.

Required qualifications:

● Bachelor's or Master's degree or equivalent combination of education and experience.

● Minimum of 15 years' experience in the medical device industry.

● Minimum of 5 years' experience in quality management.

● Experience working in Quality within catheter design and production or a similar medical device environment.

● Demonstrated experience with Design Controls, Risk Analysis, Process and Product Validation, and statistical methods.

● Applied understanding of 21 CFR 820, EN ISO 13485:2016, and ISO 14971:2019.

● Expertise in product sterilization, biocompatibility, and clean room compliance.

● Proven ability to lead through influence, manage sensitive situations, and interact effectively with executive stakeholders.

Preferred qualifications:

● Strong verbal and written communication skills with an ability to generate clear, concise, and timely reports.

● Ability to manage significant workloads, prioritize effectively, and deliver results under pressure.

● High attention to detail, accuracy, and proactive problem-solving skills.

● Strong interpersonal and listening skills, with the ability to adapt to change and build positive working relationships.

● Demonstrated success in creating realistic plans, setting goals, and executing cross-functional initiatives efficiently.

Maximum Salary: $ 197000

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:

You will oversee a diverse portfolio of initiatives ranging from small-scale tasks to large-scale process improvements, design changes, line extensions, and design transfers. This role requires close collaboration with cross-functional teams across business units and global manufacturing sites.

Your responsibilities will include:

● Develop and implement an overall sustaining strategy from product launch through end of life to ensure product continuity.

● Manage project structure and governance, including scope, roles and responsibilities, workstreams, risks, communication, and alignment.

● Develop a comprehensive set of project milestones and a project plan to define budget and resource needs.

● Guide the team through decision-making by analyzing options and presenting logical recommendations.

● Communicate project status and performance through standard reports, dashboards, and update meetings.

● Lead cross-functional teams to evaluate, design, build, and implement solutions aligned with project objectives.

● Identify, communicate, and manage technical risks and knowledge gaps.

● Serve as the liaison between the project team and leadership/governing bodies, ensuring alignment and visibility.

● Create and manage submission cadence in partnership with Regulatory Affairs to support R&D, process improvement, and business continuity projects.

Required qualifications:

● Bachelor’s degree (Master’s degree preferred).

● Minimum of 5 years' experience as a Project Manager or in a similar role leading cross-functional teams in the medical device industry.

● Strong business acumen and strategic leadership capabilities.

● Excellent written and oral communication skills with the ability to present to senior leadership.

Preferred qualifications:

● PMP certification.

● Experience working across all levels of an organization and engaging with external stakeholders.

● Strong leadership, interpersonal, and relationship-building skills within project teams.

● Technical problem-solving expertise.

● Familiarity with U.S. and EU regulatory bodies and medical device classifications.

● Proficiency in Microsoft Project.

● Experience managing projects involving catheter and console (system) components.

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:

You will oversee a diverse portfolio of initiatives ranging from small-scale tasks to large-scale process improvements, design changes, line extensions, and design transfers. This role requires close collaboration with cross-functional teams across business units and global manufacturing sites.

Your responsibilities will include:

● Develop and implement an overall sustaining strategy from product launch through end of life to ensure product continuity.

● Manage project structure and governance, including scope, roles and responsibilities, workstreams, risks, communication, and alignment.

● Develop a comprehensive set of project milestones and a project plan to define budget and resource needs.

● Guide the team through decision-making by analyzing options and presenting logical recommendations.

● Communicate project status and performance through standard reports, dashboards, and update meetings.

● Lead cross-functional teams to evaluate, design, build, and implement solutions aligned with project objectives.

● Identify, communicate, and manage technical risks and knowledge gaps.

● Serve as the liaison between the project team and leadership/governing bodies, ensuring alignment and visibility.

● Create and manage submission cadence in partnership with Regulatory Affairs to support R&D, process improvement, and business continuity projects.

Required qualifications:

● Bachelor’s degree (Master’s degree preferred).

● Minimum of 5 years' experience as a Project Manager or in a similar role leading cross-functional teams in the medical device industry.

● Strong business acumen and strategic leadership capabilities.

● Excellent written and oral communication skills with the ability to present to senior leadership.

Preferred qualifications:

● PMP certification.

● Experience working across all levels of an organization and engaging with external stakeholders.

● Strong leadership, interpersonal, and relationship-building skills within project teams.

● Technical problem-solving expertise.

● Familiarity with U.S. and EU regulatory bodies and medical device classifications.

● Proficiency in Microsoft Project.

● Experience managing projects involving catheter and console (system) components.

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:

Boston Scientific is seeking aSenior Quality Engineerto provide quality engineering leadership and support for manufacturing process development and implementation. This position partners closely with Manufacturing to ensure the production of disposable medical catheters complies with all applicable regulatory and quality system requirements.

This role plays a critical function in driving validation activities, risk management, and product lifecycle support while ensuring a robust and compliant manufacturing process.

Your responsibilities will include:

● Oversee ethylene oxide (EO) sterilization validation processes and ensure routine sterilization meets regulatory standards.

● Support environmental monitoring and cleanroom verifications per schedule; assist with excursion investigations.

● Review and approve manufacturing validation test plans, protocols, and reports.

● Lead completion of risk management deliverables, including process Failure Mode and Effects Analyses (pFMEA) and Control Plans.

● Support and lead test method validation activities to ensure reliable and accurate testing.

● Develop, review, and approve inspection plans, Device History Records (DHRs), and product drawings for new products.

● Create and implement quality plans to ensure product and process compliance.

● Drive defect prevention and detection efforts within manufacturing.

● Provide statistical support and problem-solving expertise for process validations and engineering protocols.

● Support Management Review, internal/external audits, deviations, CAPAs, NCRs, supplier management, and RGAs.

● Provide quality support for New Product Development activities.

● Lead resolution of quality issues related to CAPAs and NCRs.

● Ensure compliance with quality system procedures and applicable regulations.

Technical expertise:

● Provide technical expertise on component schematics and inspection requirements.

● Identify opportunities for improvement in both product quality and the quality system.

● Ensure accurate development and verification of Design History Files (DHFs), Device Master Records (DMRs), and Device History Records (DHRs).

● Oversee calibration and preventive maintenance programs to ensure equipment reliability (as needed).

● Manage supplier quality activities including audits, performance assessments, and quality agreements (as needed).

Required qualifications:

● Bachelor’s degree in a scientific or engineering discipline, or an equivalent combination of education and experience.

● Minimum of 5 years' experience in a regulated industry such as medical devices or pharmaceuticals.

● Experience in catheter design and manufacturing while working in Quality.

● Strong understanding of GMPs and regulatory standards (ISO 13485, ISO 14971, FDA 21 CFR Part 820).

● Proficient in interpreting engineering drawings.

● Experience with risk management records and performing risk analysis.

● Hands-on experience with test method validation and Gage R&R studies.

● Knowledge of statistical techniques including normality analysis and tolerance analysis.

● Proficient in Minitab or equivalent statistical software.

Preferred qualifications:

● Expertise in EO sterilization validation (ISO 11135).

● Knowledge of biocompatibility standards (ISO 10993 series).

● Strong analytical, planning, and organizational skills.

● Excellent written and verbal communication skills.

● Self-motivated and capable of working independently in a fast-paced environment.

● Proficiency with MS Office tools: Word, Excel, PowerPoint, Project, and Visio.

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.

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.