The Senior Quality Engineer will play a key role in the Quality function in support of Engineering and Production. This includes, but is not limited to, the development and continuous improvement of Quality Management System processes and documentation, providing design and development/sustaining support through Quality and Regulatory planning, management and execution of plans, complaint handling, root cause analysis, and quality auditing, both internal and external. Must participate on QA teams to resolve quality problems, enhance existing programs, and support a continuous improvement culture. Will be required to represent Quality Assurance on new product development and sustaining teams or to address Quality issues. Must assist Engineering groups with Risk Analysis methodologies as required. Must assist Production and Materials groups with review of nonconforming materials and processing of materials for return/corrective action. Other responsibilities include the creation of operating instructions, review and approval of Quality Management System Procedures, validation reports, and review and approval of change notices. Must additionally lead/participate on internal audit teams in conducting internal Quality Management System audits, external supplier development/audit including periodic supplier assessments, review production line failures and recommend Corrective and Preventive Actions as appropriate.
- Contribute as a core team member of product development teams, representing the Quality Assurance function in activities such as Design FMEAs and risk analysis.
- Develop quality inspection procedures, including sampling plans, for production components and finished devices. Supports Incoming Quality Control inspection in the performance of quality inspection and testing, including development of inspection fixtures.
- Support the supplier selection and qualification process with supplier audits, as well as Supplier Corrective Action Reports.
- Contribute to process validation, design verification, and design validation. Provide input regarding appropriate statistical methods, test methodologies, test facilities, and test equipment.
- Develop and maintain Quality Plans throughout the product life cycle beginning with project inception/initiation.
- Investigate nonconforming materials and provide input to Material Review Board activities.
- Coordinate sterilization validation, packaging validation, and biocompatibility testing.
- Assist in the complaint and failure investigation process, as needed.
- Conduct internal audits, as assigned.
- Maintain and comply with ZOLL SOP’s. Review procedures to ensure adequacy for device development to conform to business and Quality Management System requirements.
- Ensure that all tasks are conducted in accordance with Quality Management System procedures.
- Perform other duties, as assigned.
- Requires a B.S. degree in Engineering.
- Minimum seven (7) years experience in a medical device design, manufacturing, or quality engineering environment. Preferable experience includes capital equipment and disposable (catheter) development and manufacturing.
- Experience using Microsoft Word, Excel.