Senior Quality Engineer
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Senior Quality Engineer
Title:Senior Quality Engineer
Senior Quality Engineer:
The Senior Supplier Quality Engineer is responsible for providing support with a focus on supplier quality management activities. Works with external manufacturers and suppliers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies, procedures, and medical device regulations.
- Lead supplier quality management for legacy products and support of new products under development process.
- Lead component inspection plans, first article inspection reports (FAIR’s), and issue resolution (collaborate with Design Assurance or Quality Engineering, if design or process impacted).
- Lead corrective & preventive actions (CAPA’s), supplier corrective action requests (SCAR’s), and supplier notifications only (SNO’s) to resolution, including monitoring, analyzing, and reporting on supplier performance data and metrics.
- Lead the evaluation of new or transferred suppliers and/or changes to the Approved Supplier List (ASL).
- Lead post-launch supplier sourcing sustainment.
- Notify and present high impact to business SCN’s to Local Review Boards via Product Release Process (PRP).
- Support supplier process management, i.e., risk management, quality assurance agreements, control plans, supplier assessments / audits (QS status), submitted validations (IQ, OQ, PQ, PPQ), process failure modes and effects analysis (pFMEA), and supplier inspection plan / method evaluations.
- Utilize effective and efficient Quality Engineering techniques such as risk analysis, statistical data analysis, process capability analysis, design of experiments, measurement system analysis, control plans, and development of sampling plans throughout the product lifecycle.
- Author, collaborates and approve quality system documentation via Agile PLM.
- Perform other duties as assigned by management.
- Bachelor’s Degree in Engineering required. Master’s Degree preferred. Experience can be substituted for education requirements.
- Minimum 5 years of experience in process quality engineering in Medical Device Industry.
- Prefer experience with an emphasis on Supplier Quality Management within an FDA-regulated medical device manufacturing environment.
- Proficient with DMAIC / Black Belt / Six Sigma type tools to analyze, drive root cause, and solve problems.
- Proficient with statistics, sampling strategies, design of experiments, process capability, including statistical software tools such as Minitab.
- Strong written and oral communication skills are required.
- Proficient with process trouble shooting of parts utilizing injection and insert molding, extrusion, stamping, wire EDM, and CNC machining.
- Understanding of the design, development, and tolerancing of complex systems.
- Knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, & ISO 14971 are required.
- Ability to lead, champion change, and execute strategies to meet goals.
- Must be self-motivated with a strong sense of urgency and ability to deliver on required activities.
- Must have a sense of ownership and a desire to follow a project from inception to full production.
- Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio), including Agile PLM.
- ISO 13485 Lead Auditor certification is preferred.
- ASQ Certification (CQE & CBA) is preferred
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