Boston Scientific Senior Quality Systems Engineer 

United States, Massachusetts, Marlborough 

722054713

About the role:

Focus areas include supporting the regulatory requirements process, including monitoring, tracking, and driving completion of new or revised large scale regulatory requirements that span across BSC sites and/or Quality System functions. This role will also support global Notified Body relationships and global certificate management to ensure BSC remains complaint to EU MDR and other regulations. 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:

• Supporting the organization’s global processes for identifying, tracking, monitoring and regulatory requirements.
• Support Notified Body relationships, including audit scheduling and management, assessing quality system changes for reportability, and ensuring strong communication between Boston Scientific and the Notified Body.
• 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.
• Lead projects within or that support the Quality System Management team.
• Own NCEP and CAPA records as applicable to the role.
• Ensure the development and execution of streamlined business process which help achieve VIP/Continuous Improvement goals.
• Support internal and external audits and audit responses on an as needed basis.

Required Qualifications:

• Bachelor’s degree in science and/or engineering and a minimum of 6 years medical device/Quality System experience or Master’s degree and a minimum of 4 years of medical device/Quality System experience.
• Strong project management skills: ability to develop a project plan and manage a project through execution with minimal oversight
• Experience with NCEPs and CAPAs (non-conforming events and the corrective action process).
• 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.

Preferred Qualifications:

• Bachelors degree in engineering or equivalent experience
• Experience with working with Notified Bodies and certificate management.
• Experience with regulations, including EU MDR, 21 CFR 820, MDSAP program and ISO 13485.
• Demonstrated competency working cross functionally and globally.
• Strong communication and presentation skills.
• Ability to develop effective, positive interpersonal relationships.
• Driven, energetic, self-assured professional with high personal integrity
• Experience writing and implementing quality system procedures
• Familiarity with BSC systems such as Windchill, eCAPA

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.