Principal Quality Systems Engineer
3 weeks ago
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:
- 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.
Key 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.
- Project management experience.
- 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.
This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer.
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