Quality Engineer

JBL Resources; Redmond (WA); On-site; USD 90,000 - 120,000; Full time

Job summary

JBL is seeking a results-driven Quality Engineering professional to support medical device manufacturing quality systems in Redmond. The role focuses on non-conformance handling, CAPA, supplier quality, and process validation to drive regulatory compliance and product excellence.

Responsibilities include managing NC/CAPA records, collaborating with cross-functional teams and suppliers, executing SCAR/SICR processes, and supporting PPAP and product/process improvements across manufacturing.

Qualifications

• Bachelor’s degree in engineering, science, or a technical field.

Responsibilities

• Collaborate with operations and business teams to ensure product and process quality.

Skills

Quality management

CAPA Processes

Trackwise

Root cause analysis

Data analysis

Supplier quality

SCAR

SICR

Process validation

PPAP

ISO 13485

FDA regulations

Statistical analysis tools

Communication

Organizational skills

Education

Bachelor’s degree in Engineering/Science

Tools

Trackwise software

Statistical tools

Job description

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:

• Bachelor’s 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

**JBL is an Equal Opportunity Employer a