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Under minimal guidance the Quality Assurance Engineer provides quality support for Engineering, Manufacturing and Assembly departments. Understands quality methodologies, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and training practices. Understands quality systems and their development, documentation and implementation of internal, customer, domestic and international standards or requirements.
Essential Duties and Responsibilities:
- Investigation of, and response to, quality problems that occur from customer complaints.
- 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.
- 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.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Bachelor's degree in a technical discipline and five years related work experience including five or more years internal auditing experience and/or training.
- Certification in ISO Standards and ASQ Certified Engineer; or equivalent combination of education and experience.
- ASQ (ie CQE, CMQ/OE, etc...) and/or six sigma certification.
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