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About the role
The ideal Principal Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative electrophysiology cardiovascular products portfolio. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.
Your responsibilities include:
what we're looking for in you:
Required Qualifications
Preferred Qualifications
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.
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To ensure quality and technical standards are in place and in use ensuring product and service consistently meets customers’ requirements.
Developing and implementing continuous improvement programs covering production processes and quality management systems.
Analysis of quality problems to identify root causes and implement corrective action to reduce risk of quality failure.
The person will have a strong understanding of the requirements of and the implementation of quality management system and technical standards.
• Review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.
• Review and approval of laboratory test results
• Ensuring Data Integrity of laboratory results
• Assist in the investigation and closure of Laboratory investigations, Deviations and Out of specifications
• Communication with External Customers
• Maintenance of validation status of QC and production facilities, equipment, instrumentation and software via review and approval of planned changes and new process introduction.
• Review and approve sampling plans & procedures related to manufacture of products.
• Lead and perform risk assessments and implement control plans.
• Review and approve batch records against approved specifications, quality standards, company procedures and regulatory filings for release of product to market.
• Ensure non conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
• Support quality systems implementations and user acceptance testing where required.
• Lead in Continuous Improvement of Quality processes
• Interact and collaborate with Laboratory; Operations and other functions to support Analytical Laboratory Services and production and timely resolution of issues and investigations.
• Participate in internal audit and Shop Floor audit program
• Maintenance of professional and technical knowledge by attending educational events, reviewing publications, establishing networks and benchmarking.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties as required
Desired:
• 5+ years’ previous industrial experience of working as a Quality Engineer or Quality specialist in an ISO13485, EU GMP or 21 CFR Part 210,820 or 211 design or manufacturing environment. Aseptic or sterile manufacturing experience is desired.
• Review and approval of facility, equipment and process validation
• Analytical Method, Equipment/Process and Software Qualification
• Involvement in new product introduction or technical transfer activities.
• Quality planning and communication skills.
• Strong technical writing ability.
• Ability to liaise with customers and suppliers in an informed professional manner.
• Excellent IT, communication and interpersonal skills using current office technologies.
• Ability to work on own initiative, coupled with involvement on cross-functional teams.
• Interest and willingness to learn new skills and take on new tasks
• Strong sense of urgency and flexibility.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
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As a Sr. Staff Technical Program Manager, you will partner with key Engineering, Product, Product Design, Marketing, and Analytics stakeholders to conduct data-driven experiments and deliver features for MongoDB. As a seasoned program leader, you will be responsible for one of our most mission-critical programs this fiscal year, and own executive level communication related to the program.
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As a Staff Technical Program Manager, you will own the successful delivery of complex, cross-functional efforts. You will partner closely with stakeholders across the organization from Engineering, Product, Product Design, and even Field-facing teams to develop and execute against our overall product vision and business objectives, uncover solutions to technical challenges, and provide data-driven insights that power strategic decision-making.
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This role is a cornerstone of our Global VIP Support function, responsible for proactive, high-touch (“white-glove”) technology support for our most senior leaders and their Executive Assistants (EAs).
As the West Coast VIP Support Ambassador, you are the single-threaded owner for executive technology needs in the US Pacific time zone, partnering closely with our NYC (US/Eastern) and Dublin (EMEA) VIP specialists to deliver near 24×5 global coverage.
You will blend senior-level IT support with strong AV and collaboration expertise to protect the most critical executive workflows and events. You will also play a key role in developing and delivering IT training for the EA community, and partnering with Internal Comms and AV on All Hands support. This role requires excellent judgment, calm under pressure, empathy, and the ability to drive complex issues to resolution while maintaining executive trust.
Key Responsibilities1. White-Glove Incident Response & Resolution
2. Proactive Care, Stability, & Event / All Hands Support
3. Executive Relationship Management, EA Training & Travel Support
0–30 Days: Foundational Readiness & Onboarding
30–90 Days: Independent Ownership & Proactive Action
90 Days – 1 Year: Efficiency, Strategy & Process Ownership
Required
Preferred
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Key Responsibilities:
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