Quality Engineer

Company : Katalyst Healthcares & Life Sciences

Job Description:

Looking for a Quality Engineer that will be hands-on engineer in a role involving machining and manufacturing complex parts and products. Because this client is a manufacturer of complex, high value-engineered components in serial production, this person needs to be comfortable and familiar with this environment.

Responsibilities:

• Develops and drives measurable Quality improvements relating to products and processes.
• Experienced with First Article Inspections (FAIRs) in Aerospace and Defense that is very good with GD&T.
• Inspecting and Testing of materials, equipment, processes, and products to meet quality specifications.
• Create test and inspection method and develop and execute test method validations.
• Collaborate to develop and implement quality and process controls and improvements.
• Assure the QMS conforms to the customer, internal, industry (i.e., AS9100, ISO 9001, ISO 13485), and regulatory/legal requirements.
• Engage and support shop floor personnel and manufacturing defect prevention teams to ensure alignment on top priorities (using baseline data and future forecast). These tools are used to drive and facilitate compliance resolution, containment, Root Cause Analysis and Corrective Action Implementation within closed loop process controls.
• Lead/Drive Advanced Product Quality Planning (APQP) initiatives (PFMEA, control Plans, SPC, etc.) using baseline metrics and future demand with the ability to perform verification/validation of improvements and efficiencies to facilitate defect prevention.
• Integrate product and process verifications such as First Articles and audits throughout value stream processes to prevent quality escapes.

Requirements:

• Knowledge of Root Cause Analysis, Data analysis, and Statistical Process Control concepts.
• Experience in first article inspection reports (FAIRs), quality monitoring, and leading root cause correct actions for both short-term and long-term initiatives in a cross functional environment.
• Experience in manufacturing process knowledge with Quality systems and industry technical standards (ISO 9001, AS9100 and/or AS9102), interpreting drawings, work instructions, Bill of Materials (BOMs), consumable materials control, process disciplines and tool control.
• Experience with Advanced Product Quality Planning (APQP)/AS9145; Utilizing tools such as PPAP, Key Characteristics, DFMEA, PFMEA and/or Control Plans.
• Expertise in GDT and blueprint interpretations.
• Familiarity with using Epicor in production for productions and DMRs (Discrepant Material Reports).

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