Senior Quality Engineer, NPD Medical Device

San Antonio, Texas | Quality Assurance / Safety

Senior Quality Engineer

 

Our client is a highly successful, contract manufacturer in the medical device space.

The Senior Quality Engineer NPD is responsible for supporting new product development by applying Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and play an active role in the processes to ensure products meet quality standards consistent with all design control, validation and other regulatory requirements.

 

This location has been very successful resulting in multi-million-dollar growth for each of the last 15 years and an equally impressive growth in personnel.  As a Sr. QE you’ll interact across the breadth of the organization on a daily basis, ensuring that the requirements of the QMS are being met from concept to commercialization.

 

RESPONSIBILITIES:

  • Is knowledgeable in FDA 21CFR820, ISO 13485 and other applicable standards and their proper application in regards to Med Device Design and Development
  • Interacts cross-functionally acting as the Quality representative on NPD projects
  • In NPD, champions Process design and development including validation protocols, testing and reporting
  • Understands the principles of Risk Management, their proper application and practices
  • Identifies CTQ’s for product/process characterization and applies FMEA & DOE’s for validation activities
  • Is an independent reviewer during the Design Review process
  • Ensures Quality & Control plans are created and effectively implemented
  • Works with manufacturing QE’s warranting the efficient transfer of product and process to Operations
  • Coordinates with Supplier Quality on the qualification process including test methods, inspection standards, equipment and systems for the NPD group
  • Supports Regulatory during audits of Design Control
  • Works with operations to rationalize issues related to previously transferred and launched products
  • Assures that proposed process and procedures fit the organization’s quality standards
  • Builds testing models for materials from ‘raw’ to in-process and including finished goods
  • Heavily involved in quantitative/qualitative analysis, summary and reporting
  • Inputs his/her expertise in equipment selection, installation and maintenance
  • Has an in-depth level of knowledge in GD&T
  • Leads Root Cause investigations, develops CAPA plans, verifies effectiveness of related activities
  • Mentors and supports other team members

REQUIREMENTS:

  1. BS in Engineering or other technical discipline
  2. 8 years’ experience in a med device design and development environment in Quality
  3. Demonstrable experience in Design Control and Product Lifecycle
  4. Must have GD&T with experience in drawing interpretation and gage design
  5. Automated inspection system experience
  6. Proficiencies in common Quality methodologies like APQU, MSA, PPAP, SPC
  7. Experience with Lean/Six Sigma methodologies is preferred
  8. Must be proficient in the use of the MS Office Suite
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