Principal Quality Systems Engineer - Cardiac Rhythm Management & Diagnostics; CRMDx

Position: Principal Quality Systems Engineer - Cardiac Rhythm Management & Diagnostics (CRMDx)
Additional Location(s):  N/ADiversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:

This Principal Quality Systems Engineer serves as a Design Control representative leading awareness, visibility, and communication of quality initiatives in support of global and CRM quality goals. This role is responsible for compliance of the CRM Design Control to BSC Global Quality System and applicable regulatory requirements and standards.  Work Mode:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Relocation Assistance:

Relocation assistance is not available for this position.

Visa Sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

Your responsibilities will include:

Deliver and manage completion of CRM divisional deliverables, including updates to procedures, Work Instructions, and knowledge sharing documents

Active membership of Global Procedural and Design Control Community of Practice Drive and provide guidance to team members regarding quality strategies driven by BSC Global Quality System Provide project direction, coaching, and mentoring for engineering and technical team personnel

Work cross-functionally in identifying and resolving procedural issues

Drive continuous improvement initiatives to enhance CRM Design Control Process and its efficiency while maintaining or improving product quality

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Advise management on potential improvements or enhancements to quality systems and processes in the company. Promote a culture of quality and compliance within the organization through regular communication and training.

Provide essential support during internal and external audits by presenting Design Control storyboard in front room and addressing questions related to CRM DC process. Provide back room support by supplying necessary documentation and leading DC backroom stream.
Establish or maintain CRM design control procedures, templates, and tools

Required Qualifications:

Bachelor’s degree in science, Engineering, Health, or related fields Minimum of 8 years of work experience in the medical device or other regulated industry

Solid computer skills required including Excel, Word, and Power Point Strong  communication skills (verbal and written)

Preferred Qualifications:

Working knowledge of US and International regulations and standards applicable to BSC including 21 CFR 806 & 820, ISO 13485:2016

Project management experience

Experience with in BSC quality systems

Experience with Design Control process

Experience working with cross functions teams such as Regulatory, Research and Development, Clinical, and Quality Strong presentation skills

Travel is very limited, maybe up to 10%

Requisition  Salary: $ 102100

Maximum Salary: $ 194000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of…