US - Quality Engineer-Sr

7 days ago

Austin, TX, United States Sunrise Systems Full time
Job Title: Quality Engineer-Sr
Job ID: 25-11153
Location: Austin, TX
Duration: 07 Months on W2 contract

The Senior Quality Engineer (QE) actively pursues the on-going compliance of the Client North Austin Quality Management system with a focus on process maintenance, measurement and analysis, continuous improvement activities, and representation of the site during internal and external audits. The Senior QE exhibits quality principles across functions and coaches other engineers in the use of formal root
cause investigation tools. This role primarily supports onsite operational and inspection processes for the site's orthopedic devices.

What will you be doing?
  • 20% - Lead the development and implementation of quality programs to ensure products and processes conform to product specifications and applicable regulations.
  • 20% - Responsible for continuous improvement efforts with respect to Quality Controls to eliminate/reduce future recalls and ensure regulatory requirements and standards are met.
  • 20% - Leads/Participates in CAPA and other non-conforming investigations. Identifies appropriate actions in response. Acts as investigation Subject Matter Expert (SME) for the site.
  • 20% - Works directly with cross functional teams including Operations, Regulatory, Product Development, Supplier Quality, and PMO to ensure projects meet quality system requirements. Supports successful on time launches of new products and process transfers.
  • 10% - Leads or assists in gathering data and formulating strategy for risk-related activities, including MSA, GRR, and FMEA. May also present these risk related statistics to facilitate decision-making for product, processes, or business.
  • 5% - Prepares strategy for and represents the site during internal and external audits.
  • 5% - Other activities as identified and/or agreed with the Site Quality Lead.
What will you need to be successful?

Education: Bachelor's degree in engineering discipline

License/certification: American Society of Quality (ASQ) certifications, such as Certified Quality Engineer, preferred but not required.

Competencies:
  • Strong working knowledge in FDA and/or ISO regulations is required.
  • Ability to assess and incorporate technical standards associated with Quality Operations responsibilities.
  • Experience: Six years of quality engineering experience. Experience with sterile medical devices and clean room activities is desired but not required.


Top 3 Skills:
  • Quality inspection experience
  • Product lifecycle management system
  • ERP systems experience, SAP is a plus


Contact:
Sunny Rajput | sunny.r@sunrisesys.com | 732-719 - 5899 | URL: www.sunrisesys.com

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