Supplier Quality Engineer II at TalentBurst

Position: Supplier Quality Engineer II, Req#: 9224-1
Location: Irvine, CA (100% Onsite)
Duration: 12+ Months Contract

Job Description:

The Supplier Quality Engineer II will play a key role in critical projects within the Transcatheter Mitral & Tricuspid Therapies (TMTT) business unit. This position is cross-functional 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 on-site in a very fast-paced and dynamic environment where being proactive and taking the initiative is paramount to success.

Education and Experience:

• Bachelor’s 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 Master’s degree in engineering or scientific field with no experience (or internship/co-op experience).
• Experience with Gauge R&R and Test Method Validation
• Preferably experience with process validations IQ, OQ and PQs
• Supplier quality management and receiving inspection experience
• Knowledge of statistical analysis. Specifically, process capability, PPK, P-value, and normality assessments
• Knowledge of the medical device and familiarity with a manufacturing process
• Minitab, Microsoft Project, IGNITE/Windchill used for PLM, supplier systems like IQVIA/JD Edwards, SolidWorks is a plus (3D is great)
• Previously experience with creating RI routers new components
• Worked on NCRs and supplier communication to troubleshoot
• Candidates must be team-oriented and has a proven track record working in a cross-functional team
• Effective communicator not afraid to speak up and articulate overall issues
• Organized, track record of following tasks and hitting deadlines
• Highly regulated industry experience.
• Must have the ability to travel up to 25%

Preferred Qualifications:

• Medical Device, Aerospace, or Automotive industry experience.
• Knowledge and understanding of FDA’s 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 non-conformance 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 multi-task, while maintaining high attention to detail
• Ability to achieve results in a cross-functional team environment and build strong relationships with internal and external customers(suppliers)
• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

Job Responsibilities:

• Facilitate/perform gauge 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 designing and creation 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 on-site supplier audits.
• Manage supplier-related non-conformances.
• 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 the manager