This individual will ensure the development of a comprehensive risk management plan for the product and processes as well ensure effective quality strategies for validations. This individual will ensure the development and validation of appropriate test methods for product and process performance. Ensure effective and consistent application of Quality Engineering and Process Excellence tools and techniques. Additionally, this individual will ensure active and thorough investigation of quality issues and effective corrective and/or preventive action.
Principal Duties and Responsibilities:
- Direct Failure Mode and Effects Analysis activities for both Design and Process FMEA's. Ensure effective risk management to prevent unanticipated failure modes and ensure capability.
- The Quality Engineer will function as a project team member in matters relating to Quality Engineering such as planning and executing project milestones.
- Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, (Gage R&R), statistical data analysis, statistical process control, and development of sample plans.
- The Quality Engineer will utilize Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
- Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
- This individual will utilize Quality Engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
- Asseses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable.
- Recommend issue resolution to senior management for significant capability and compliance issues.
- Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
- Participate in MRB review of nonconforming product; recommend disposition and corrective action.
- Developing, applying, revising, and maintaining quality standards for processing raw materials and/or reliability of products and/or components into partially finished and/or finished products.
- Perform both internal and supplier quality system audits
- Generate, review and approve engineering change notices (ECN)
Job Specification (minimal requirements):
1)A minimum of a Bachelor's degree is required, preferably in Engineering, a Life Science, a Physical Science, Chemistry, or Business.
2)A minimum of 4 years of prior work experience in a Quality function is required. Certified Quality Engineer (CQE) (ASQ or equivalent) is preferred.
3)At least 3 years working in Medical Devices industry.
4)Attention to detail and accuracy, good organizational and planning skills.
5)Demonstrated the ability to meet deadlines.
6)Solid oral and written communication skills.
7)Primary responsibilities include working with other functional groups in support of new product development and sustaining manufacturing processes.