Quality Engineer

Spellman High Voltage Electronics Corporation takes pride in powering progress in health, security and quality of life. We are key partners with the world’s leading medical devices, semiconductor, scientific analytics and industrial systems manufacturers. When they want to push the limits of what’s possible with high voltage applications, they turn to us to make it happen.

Quality Engineer

• Identify factory yield or process issues and drive root cause corrective actions using CAPA 8D process.
• Provide timely and concise communication and escalation of issues to Director and VP of Quality and to other relevant departments. This includes, but is not limited to, weekly activity reports, monthly and quarterly updates, and other updates as needed.
• Proactive engagement with and response to Engineering, Operations and Sales
• Create, monitor and improve a consolidated Quality Management data reporting system
• Analyze quality data to identify issues and trends and initiate appropriate corrective actions, drive the corrective actions to a systematic root cause solution.
• Provide Quality support to Product Development for design control and verification/validation to drive Quality Improvement
• Drive Corrective Action/Preventative Action (CAPA) activities using core quality tools to ensure proper identification of causal factors and/or true root cause and to develop solid corrective action that will ensure this issue does not reoccur.
• Additionally, CAPA’s are to be reviewed across all products and operation to ensure the potential risk from this same type of issue is mitigated across the entire organization.
• Address actual and potential Quality and Regulatory Issues. Revise work instructions and quality documents as required
• Develop and monitor Quality goals and objectives for services and processes. Assist in defining and implementing strategies to meet Key Performance Indicators
• Actively participate in the New Product Introduction process through the development & implementation of elements of APQP such as FMEA, PPAP, Control Plans, Gauge R & R, Failure Analysis, Process Controls, and Data Analysis.
• Review and approve Engineering Changes (ECNs) for accuracy and completeness of information and impact to customers, including approval/notification requirements.
• Ensure customer satisfaction by monitoring customer complaints, customer returns, and other customer related issues, creating CAPA for each issue, ensuring identification of true root cause and implementation of effective corrective actions.
• Actively participate in Supplier and Customer business reviews. Prepare quality data ahead of time, assist in development of standard quality presentation and prepare this material for review with customers and/or suppliers, present the material and take away action items as necessary.
• Evaluate and rollout “Best Practices” while driving systems and process-based organization.

QUALIFICATIONS:

• Minimum of 3 years experience as a Quality Engineer.
• BS/MS in Electrical Engineering or related field
• Experience working for a multinational company and the ability to communicate effectively across language and cultural barriers
• Experience implementing and sustaining Quality Management Systems
• Expert knowledge, application and deployment of quality tools
• ISO 9000 & 14001 experience
• FDA Regulatory experience
• Strong project management skills
• Strong organizational and time management skills
• Strong SMT, TH and large system electronic assembly experience
• Lead Free (RoHS) experience
• Strong SPC Experience (Control Charts, Pareto Analysis, Histograms, FMEA’s, etc.)
• Experience in Design of Experiments (DOE)
• Experience with electrical, mechanical and electro-mechanical assembly, dielectrics, injection molding and PCB’s
• Lean Experience/Six Sigma Experience
• Proficient in Word, Excel, Project, Power Point, Minitab as well as hardware and software tools to accomplish day to day work activities.

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