Boston Scientific Quality Specialist II 

United States, Minnesota, Arden Hills 

326194858

About the role:

Collaborates with Quality management to recommend, design and implement functional process improvements. Develops, establishes and maintains quality methodologies, systems and practices which meet BSC, customer and regulatory requirements. May own and develop metrics and support measuring performance to quality objectives. May provide compliance guidance and support for technical development concepts, regulatory, operational, or systems/services.

Your responsibilities include:

• Support the development/enhancement of product data quality systems.
• Support data management activities.
• Support compliance analysis and metrics.
• Participates in projects supporting Best 4 Quality
• Leads and/or participates on NCEP/CAPA teams.
• VIP project management
• Procedure management and ownership
• Develops and delivers communication and training.
• Other duties as necessary or required by the department or organization.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Required Qualifications:

• Bachelor's degree and 1-3 years of work experience
• Complaint handling experience
• Ability to read, analyze and report data.
• Excellent written and oral communication
• Strong sense of responsibility and attention to detail
• Ability to actively engage divisional and regional resources.
• Ability to work with a virtual team.
• Microsoft Office Suite skills (Excel, Word, PowerPoint, SharePoint)
• Experience with Microsoft Dynamics 365, Help Desk Ticket System, Azure DevOps
• Experience as an NCEP/CAPA owner.
• Understanding of quality management systems
• Understanding of data management / information management
• Project management experience
• Technical writing and editing skills.

Preferred Qualifications:

• 2-3 Years of experience
• Previous Quality Assurance or complaint handling experiences preferred.
• Team player with excellent coordination, interpersonal and communication skills.
• Self-directed requiring minimal supervision.
• Understanding of the Boston Scientific Cardiac Diagnostics quality system
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement/ The foal 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.