We are looking for a Quality Engineer to join our client in Sturbridge, Ma on a direct hire basis.
The Quality Assurance Engineer will have primary responsibility for tracking the development process of a product from start to finish. You will oversee production, testing each part to ensure it meets company standards before moving to the next phase. The goal is to create safeguards for products to be market-ready and meet all internal and customer standards.
- Investigation of, and response to, quality problems that occur from a customer complaint.
- Interface to customer for quality related items and customer audits.
- Participate on design transfer, design control and improvement project teams.
- Conduct Quality training as applicable.
- Perform root cause analysis of product quality issues. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.). Work with peers to develop corrective actions.
- Perform failure mode analysis on new or existing products. Working with peers, develop mitigations for failure modes, and verify the effectiveness of these mitigations.
- Execute risk assessments and provide recommendations for management consideration
- Support production improvements by utilizing SPC techniques and tools such as JMP.
- Identify and help facilitate continuous improvement, corrective and preventive actions.
- Pursue activities for continuous improvement related to ISO 9001 and ISO 14001
- Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP) and ISO requirements
- Periodical product quality check through internal process audit and external supplier audit.
- For both new products/processes and changes to existing products/processes develop verification and validation plans that assess if requirements are met. Oversee the execution of verification and validation plans. Write reports that summarize the verification and validation results.
- Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
- Support the NC and CAPA processes by performing investigations and root cause analysis, determining action plans and driving the actions to closure.
- Investigation of quality problems and thereafter, implementation and verification of corrective action with focus on the prevention of reoccurrence through follow-up.
- Investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection
- Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements.
- B.S. degree or equivalent. An engineering or science background is preferred.
- Minimum of 8 to 10 years related experience in quality assurance positions that have customer-facing responsibilities.
- Proficient in MS Office Suite
- Knowledge of statistical techniques such as Statistical Process Control for manufacturing process improvement and JMP application for data analysis.
- Statistical tools including basic statistical inference, graphical methods, regression
- Experience with root cause analysis, failure mode analysis, verification, and validation
- ASQ (ie CQE, CMQ/OE, etc...) and/or six sigma certification a plus
- Analytical/Problem Solving Skills (e.g. statistical, risk analysis, engineering analysis)
- Knowledge of measurement precision / capability analysis techniques such as gauge R&R.
- Ability to generate and maintain monthly reports.
- Ability to effectively communicate in English (both oral and written).
- Comfortable speaking to, and in front of all levels of management.
- Familiarity with use of mechanical and electrical test equipment
- Ability to analyze and aggregate data using statistics
- Experience in an ISO 9000 environment and able to maintain ISO documents and record control.