Sr. Quality Systems Manager - Supplier Controls
About The Position
Bachelor's degree in Science, Health, or Engineering 10+ years of relevant work experience in the medical device regulated industry Experience in supplier qualification, material qualification, and change control for direct materials. Experience with CAPAs (Corrective and Preventive Actions) and audit support Project management experience Strong presentation skills Strong communication skills Solid computer skills required including Excel, Word, Project and PowerPoint Potential global and US travel up to 10% MBA, or Master of Science Working knowledge of US and International regulations and standards applicable to BSC including 21CFR820, ISO 13485:2016, MDR and regional requirements Technical experience within the areas of Material Controls and Quality Management Systems Experience working with cross functions such as Quality Systems, Operations, Manufacturing Engineering, Sourcing, Regulatory, Research and Development, and Design Assurance. ASQ Certified CMQ/OE, CQE, CQA are a plus
Requirements
- Bachelor's degree in Science, Health, or Engineering
- 10+ years of relevant work experience in the medical device regulated industry
- Experience in supplier qualification, material qualification, and change control for direct materials.
- Experience with CAPAs (Corrective and Preventive Actions) and audit support
- Project management experience
- Strong presentation skills
- Strong communication skills
- Solid computer skills required including Excel, Word, Project and PowerPoint
- Potential global and US travel up to 10%
- Working knowledge of US and International regulations and standards applicable to BSC including 21CFR820, ISO 13485:2016, MDR and regional requirements
- Technical experience within the areas of Material Controls and Quality Management Systems
- Experience working with cross functions such as Quality Systems, Operations, Manufacturing Engineering, Sourcing, Regulatory, Research and Development, and Design Assurance.
Nice To Haves
- MBA, or Master of Science
- ASQ Certified CMQ/OE, CQE, CQA are a plus
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
