Description / Descripción
The Manufacturing/Quality Engineer provides overall Quality guidance and execution in the production Medical products. As a liaison with production associates, the Manufacturing/Quality Engineer leads and ensures production and quality requirements are communicated and understood, resolves quality-related concerns related to the supply chain, conducts supplier assessment and oversight activities, and supports verification/validation activities. Provides analysis and recommendations needed to allow manufacturing to produce to the engineered product designs. Provides effective communication and services in solving production problems or pursuing operations improvements. The Manufacturing Quality Engineer will report directly to the Quality Manager.
- Provide product and process DFM (Design for Manufacturing) input to enhance manufacturability and product cost.
- Collaborate with suppliers and manufacturing to create an efficient assembly process, specifying and/or refining BOMs, workflow processes, and detailed work instructions.
- Provide technical support analyzing and/or performing failure analysis for discrepant production components, and assemblies.
- Manage outside vendors to ensure quality specifications of raw materials are met.
- Lead/participate in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining of the supply chain.
- Manage supplier organizations to remedy non-conforming goods while maintaining positive and productive working relationships
- Read, understand, and verify bills of material (BOMs), assembly drawings, engineering tolerances, and other technical information
- Create and/or review ECO’s
- Define First Article acceptance criteria and ongoing Receiving Inspection criteria with assistance from the Production team
- Oversees documentation of non-conforming material, supplier corrective actions, and works with suppliers to define root cause and verify effectiveness of actions taken
- Performs onsite supplier evaluations and reviews supplier’s processes against Medical supplier quality standards.
- Makes recommendations to management regarding supplier selection
- Assists the Operations team in implementing change orders
- Develop and report leading metrics of supplier performance to cross-functional management team.
- Develop and lead supplier process improvements that minimize production costs and defects
- Perform supplier qualification and assessment activities
- Implement and monitor process capability for continuous improvement
- Understand schedules and capacity to ensure suppliers are prepared to meet production demand
- Apply Quality concepts and tools to drive safety, accuracy, and productivity within the supply chain and company
- Bachelor’s degree or higher in a related Engineering discipline (preferred Manufacturing, Mechanical or Industrial Engineering degree) from an accredited university.
- 5+ years of manufacturing engineering /quality engineer preferably in a regulated environment such as ISO13485 or 21 CFR 820.
- Strong leadership, conflict resolution, and negotiation skills required
- ASQ Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE) are a plus
- Six Sigma Certified (Green or Black Belt) a plus
- Knowledge of quality practices and procedures, including use of KPI’s and statistical analyses
- Knowledge of ERP processes and systems; experience with web-based ERP systems
- Thorough knowledge of manufacturing processes and concepts
- Ability to evaluate data, resulting in corrective and preventive actions
- Effective communicator, problem solver, and self-starter; works well in a team environment
- Ability to perform work accurately and thoroughly.
- Intermediate to advanced computer skills. Proficient with MS Office and other work-related software