Engineering - Engr II
Engineering - Engr II
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Job Description
Role: Supplier Quality Engineer II
Location: Irvine CA 92606 (Onsite Role)
Duration: 12 Months of contract role to begin with possible extension
Job Description:
The Supplier Quality Engineer II will play a key role on critical projects within the Transcatheter Mitral & Tricuspid Therapies (TMTT) business unit.
This position is crossfunctional in nature and requires strong collaboration and partnership with R&D Design Assurance Operations Regulatory Affairs Supplier Development Engineering and Receiving Inspection.
The primary focus of the position is leading successful part qualification efforts with external suppliers to support product development and commercial launch timelines.
The Supplier Quality Engineer II will work onsite in a very fastpaced and dynamic environment where being proactive and taking initiative are paramount to success.
How you will make an impact:
- Facilitate/perform gage studies process capability studies and supplier process validations related to critical component features based on risks identified in FMEAs.
- Develop and validate test methods which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
- Create test method procedures and provide training.
- Provide engineering support to Receiving Inspection on component test methods and investigations.
- Support component specification development identification of critical features development of inspection methods and plans test method validation process validations and component capability assessments
- Supports risk management activities including the development and implementation of FMEAs process control plans and quality agreements at suppliers
- Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities
- Conduct onsite supplier audits. Manage supplierrelated nonconformances.
- Manage supplier corrective action requests from initiation to closure.
- Collect and analyze Quality metrics relating to Supplier Quality Communicate supplier quality risks to upper management during Management Review and project meetings and identify solutions to mitigate risks.
- Support process and system improvement projects as assigned by manager
What youll need (Required Qualifications):
- Bachelors degree in engineering or scientific field with at least 2 years of experience with either supplier quality quality manufacturing R&D or production engineering activities; OR Masters degree in engineering or scientific field with no experience (or internship/coop experience).
- Highly regulated industry experience.
- Must have ability to travel up to 25%
What else we look for (Preferred Qualifications):
- Engineering degree Medical Device Aerospace or Automotive industry experience.
- Knowledge and understanding of FDAs 21 CFR Part 820 ISO13485 ISO9001 and other International Regulatory Standards.
- Experience and/or proficient knowledge of Design Controls and test method development/validations.
- Experience with statistical techniques and tools such as Gage R&R Statistical Process Control or Process Capability Studies.
- Ability to conduct effective root cause analysis; driving nonconformance investigations; and assessment of corrective action strategies and effectiveness as applied through CAPAs.
- Knowledge of GD&T and ability to read and interpret drawings.
- Good understanding of process validations (IQ OQ PQ)
- Good understanding of manufacturing processes (i.e. injection molding extrusion machining etc.).
- Good interpersonal skills with the ability to negotiate and influence change.
- Possess the ability to multitask while maintaining high attention to detail
- Ability to achieve results in crossfunctional team environment and build strong relationships with internal and external customers(suppliers)
- Aligning our overall business objectives with performance we offer competitive salaries performancebased incentives and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
Trinus Corporation a leading provider of technology solutions and services with over 25 years of experience is a certified WBE/MBE/SBE/SDB firm accredited by WBENC NMSDC and SBA. Our mission is to shape the future of work by aligning the right mix of people process technology and innovation to efficiently meet our clients business objectives. At Trinus we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit. To learn more about us please visit our website
Employment Type
Full Time
