Boston Scientific Quality Systems Engineer 

United States, Massachusetts, Marlborough 

619273492

About the role:

The Marlborough Quality Systems team is responsible for providing cross-divisional Quality Systems support through coordination of various elements within the Quality System Management and CAPA processes within the BSC Global Quality System for the Endoscopy and Urology divisions. This position provides technical guidance and leadership to Design Quality engineers and other personnel on compliance with BSC and external requirements. This is accomplished by liaising with cross functional SMEs to gather data in support of corporate and site goals and objectives. This position drives a culture of continuous improvement and collaboration within the Quality systems and Design Quality groups.

Your responsibilities include:

• Coordination and preparation of information for CAPA, NCEP and general metric meetings and ability to present this information
• Support site corrective and preventive actions process as a CAPA Mentor
• Work with project teams to create timelines, identify root cause and identify solution pathways
• Partner with CAPA owners to complete phases in a timely manner.
• Analyze data as needed to ensure Marlborough site meets necessary CAPA and NCEP metrics
• Monitor and improve site CAPA implementation aging and identify opportunities for improvement
• Develop and foster strong relationships with divisional management and key stakeholders within the Marlborough site
• Promote a culture of compliance to regulations, standards and procedures throughout the Endoscopy and Urology divisions
• Champions continuous improvement activities
• Identify opportunities for preventive activities for the Marlborough site
• Actively engage and participate in Communities of Practice as a Marlborough representative
• Quality Notification Coordinator for the Marlborough Site
• Support external audits and Complaint Review Board process, as required
• Manage and maintain Marlborough Real time aging process

Minimum Requirements:

• Bachelors degree or 4+ years work experience in Quality/ corrective and preventive actions
• Strong organizational, analytical, and problem-solving skills with good attention to detail
• Strong interpersonal skills, ability to influence and work with others in a positive and collaborative manner
• Excellent communication and presentation skills both written & oral
• Ability to manage multiple projects
• Demonstrated ability to identify and work with cross functional teams to solve problems
• Ability to rapidly learn and use new applications

Preferred Requirements:

• Previous experience in Quality Assurance, Quality Engineering or Quality Systems background
• Experience in the medical device industry
• Working knowledge of regulations and standards related to medical devices
• Working knowledge and understating of QSR, ISO, EU MDR and other medical device industry quality requirements
• Previous experience with BSC systems (Windchill, eCAPA, SAP, etc.) or similar
• Proven ability to work well as part of a team or alone with minimum supervision

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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.