SR SUPPLIER QUALITY ENGINEER (#13-5876) AccessClosure
The ideal candidate is an independent, well-organized self-starter who thrives in a fast-paced environment and can independently juggle work priorities. A relationship-builder, you take a creative yet efficient approach to product quality, establishing supplier evaluation criteria and accountability. You are
comfortable making decisions under pressure and exhibit a calm, efficient presence when faced with escalated turnaround times and/or sudden changes in daily work demands.
Responsible for the Supplier Quality Control system. Partner with internal departments and Suppliers to efficiently deliver safe and effective medical device designs and processes for manufacturing in line with AccessClosure?s policies and procedures. This includes supporting project teams on new and existing products to ensure that processes and products are designed and developed in accordance with customer, corporate and regulatory guidelines.
Essential Duties And Responsibilities
Other duties may be assigned on an individual basis
Responsible for the management of the Supplier Quality System including:
Supplier approval process including off-site manufacturing suppliers
Schedule and conduct Supplier audits, including off-site manufacturing suppliers
Present quality metrics as it relates to Supplier performance to Senior Management
Manage and investigate CAPA?s as they relate to Supplier quality performance
Direct interface with Suppliers relating to quality performance
Create and implement process improvements to the Supplier Quality System
Establishes measurement systems to monitor effectiveness of quality and reliability systems as they relate to supplier performance and component acceptance
Identifies, corrects and prevents defects
Assists with root cause analysis and corrective actions for Non-conformances related to components and other supplier related issues
Provide guidance to inspectors in the understanding of specifications, inspection technique and quality workmanship standards
Provides guidance to the engineering staff for the risk based approach to establish the sampling plan for components
Manages the quality related aspect for transition of manufacturing processes to off-site manufacturing suppliers
Represents the Quality department as a subject matter expert in External and Internal audits for Supplier Quality and other responsible areas
Education / Experience
Bachelor Degree in Engineering or related discipline
Minimum of 5 years related work experience with at least 3 years in the medical device field
Ability to perform multiple tasks concurrently with accuracy
Must have demonstrated hands-on experience in:
FDA Good Manufacturing Practices
ISO 13485, 21CFR Part 820
Clear and effective communication skills
Proficiency in MS word, Excel and PowerPoint required
High attention to detail and accuracy is required
Working knowledge of SPC & Process Capability strongly preferred
Technical expertise in a commodity, such as extrusion or injection molding strongly preferred
Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials.
Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
Work includes potential exposure to chemicals.
Work include travel up to 25% (including some international)
May supervise Engineers or Technicians
||Santa Clara, CA |