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Quality Engineer 2nd shift (Redmond)
Quality Engineer 2nd shift (Redmond)JBL Resources • Redmond, WA, United States
Quality Engineer 2nd shift (Redmond)

Quality Engineer 2nd shift (Redmond)

JBL Resources • Redmond, WA, United States
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Quality Engineer (2nd Shift)

Location : Redmond, Washington

About Our Client :

Our client is a highly sought after Fortune 500 Medical Device organization looking for results driven professionals like you! This facility focuses on Class III electromechanical ALS & BLS devices used around the world. Offering an environment where collaboration and results are equally important, this highly sought after company has a global reputation for growth and company culture.

Key Responsibilities :

  • Working closely with operations and business teams to ensure product and process quality performance.
  • Collaborating with internal cross-functional teams and suppliers to address and resolve top quality issues.
  • Owning and managing identified internal and supplier-driven non-conformances (NC) and corrective action preventative action (CAPA) records, ensuring timely processing and closure in Trackwise.
  • Supporting execution and analysis of manufacturing-related complaint investigations and product field actions.
  • Investigating and dispositioning internal non-conforming product within the material review board (MRB), issuing NCs as needed.
  • Communicating and collaborating with suppliers regarding non-conformances and escalating supplier corrective action requests (SCAR) as required.
  • Executing and managing supplier-initiated change requests (SICRs), engaging with cross-functional teams for assessment and approval.
  • Supporting manufacturing transfers to and from other plants or facilities, ensuring the execution of appropriate quality activities.
  • Collaborating with stakeholders to identify and execute opportunities for supplier part certification.
  • Engaging in the development and improvement of internal manufacturing and distribution processes for existing products.
  • Performing critical assessments and qualifications of internal and supplier-proposed change management activities, including production part approval process (PPAP) for supplier changes.
  • Participating in and potentially leading the creation and review of new or modified quality procedures.
  • Supporting the development and review of process and equipment validation / qualification and measurement system analysis (MSA) of internal processes.
  • Maintaining and analyzing key performance indicators (KPIs) to monitor process and product quality, identifying trends, and taking appropriate action as necessary.

Qualifications :

  • Bachelors degree in an Engineering, Science, or technical field required.
  • Experience with quality management systems, non-conformance handling, and CAPA processes.
  • Proficiency in using electronic quality management systems such as Trackwise.
  • Excellent communication skills for collaborating with internal teams and suppliers.
  • Strong problem-solving skills with the ability to analyze data and drive root cause investigations.
  • Strong organizational skills with the ability to manage multiple priorities effectively.
  • Understanding of manufacturing processes and quality control methodologies.
  • Ability to work independently and proactively address quality concerns.
  • Experience with supplier quality management, including SCAR and SICR processes, is preferred.
  • Familiarity with process validation, PPAP, and manufacturing process improvements is a plus.
  • Knowledge of regulatory requirements for medical devices (ISO 13485, FDA regulations) is preferred.
  • Proficiency in statistical analysis tools and quality engineering methodologies is a plus.
  • NO C2C CANDIDATES
  • Interested Candidates please apply on our website at https : / / jobs.jblresources.com.

    For more information about our services and great opportunities at JBL Resources, please visit our website : https : / / www.jblresources.com.

    JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.

  • JBL is an Equal Opportunity Employer a
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