Boston Scientific Quality Systems Engineer II 

United States, Massachusetts, Marlborough 

510336070

The Quality Systems Engineer II will be part of the Global Quality Systems Team. This role will serve as a backup for Corporate Audit Support during heavy audit periods within the year. This includes supporting audits across the BSC network and assisting with planning and preparation for Corporate Headquarters audits. In addition, this individual will be responsible for supporting the process owner for activities related to the Regulatory Requirements process, assisting with monthly Quality System Governance Board meeting preparation and execution, and supporting the process owner with the Standards Management process. Additional activities that support continued compliance to Quality System requirements and best in class audit performance will be identified and assigned as necessary.

Your responsibilities will include:

• Backup to the Corporate Audit Support function on an as needed basis, including, but not limited to:
• Supporting site audits
• Coordinating audit requests across the BSC network
• Planning, preparation, and execution of Corporate Headquarters audits
• Present and participate in External Audit Community of Practice
• Assisting off hours
• Maintaining external audit documentation/SharePoint site as needed
• Work with the owner of the Regulatory Requirements and Standards Management processes to assist with tasks, such as monitoring status of open or ongoing assessments.
• Work with the process owner/facilitator of the Quality System Governance Board to assist with meeting preparation, execution and deliverables.
• Interface with Global Quality process and sub-process owners, site quality leads, cross-functional subject matter experts to ensure audit readiness across the organization.
• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Advise on potential improvements or enhancement to quality systems and processes in the company.
• Drive project work within Quality System Management team.

Required Qualifications

• Bachelor’s degree in science and/or engineering and 3+ years medical device/quality system experience or Bachelor’s degree and 5+ years of medical device/quality system experience.
• Understanding and working knowledge of applicable regulations and standards, including EU Medical Device Regulation (EU) 2017/745, ISO 13485, MDSAP, 21 CFR.
• Proficiency with Microsoft Office suite, including SharePoint.
• Ability to travel up to 10%

Preferred Qualifications

• Bachelors degree in engineering or equivalent experience
• Applies continuous improvement principles in the development of the quality system
• Strong communication and presentation skills
• Ability to work independently with minimal oversight
• Ability to develop effective, positive interpersonal relationships
• Ability to adjust work hours to accommodate a global audit schedule that spans time zones
• Experience with audit support
• Audit experience (front room / back room / auditing)
• Driven, energetic, self-assured professional with high personal integrity
• Ability to coordinate and lead groups of people towards a common goal
• Data visualization and presentation
• Experience writing and implementing quality system procedures
• Familiarity with BSC systems such as Windchill, eCAPA
  

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.