Principal Quality Systems Engineer

About the role:
This position 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.

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 PowerPoint.
• 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.
• Experience within BSC quality systems.
• Experience with Design Control process.
• Experience working with cross functions teams such as Regulatory, Research and Development, Clinical, and Quality.
• Travel is very limited, may be up to 10%.

Requisition ID: 593609