Quality Engineer

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