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Staff Continuous Improvement Quality Engineer
2 months ago
This is an exciting opportunity to join Abbott Laboratories as a Staff Continuous Improvement Quality Engineer in the Electrophysiology Division. As a key member of our team, you will play a critical role in driving process improvements and ensuring the highest quality standards in medical device manufacturing.
Key Responsibilities- Provide leadership to engineering staff regarding process validations and continuous improvement activities.
- Mentor engineers in the proper methods of process validation, including installation qualification (IQ), operational qualification (OQ), and process qualification (PQ).
- Use industry-standard methodologies (lean, six sigma, DFX, etc.) to drive efficiency improvement across the manufacturing network.
- Monitor, assess, and improve in-process production, inspection, and assembly performance to ensure customer requirements are maintained, and process/business performance metrics meet goals.
- Determine and drive operations-focused improvement efforts based on data analysis.
- Oversee the implementation of countermeasures and corrective/preventive actions in support of operations process improvements.
- Support continuing production, process development, and new product introductions.
- Participate in cross-functional teams.
- Review and approve protocol and written reports.
- Drive continuous improvement of engineering technical capabilities.
- Prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis.
- Coach, manage, and develop technical staff.
- Develop, implement, train, and monitor the effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP, and all other applicable agency regulations.
- Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Minimum of 8 years of experience in manufacturing/process development leading and supporting continuous improvement programs within medical device manufacturing.
- Experience conducting and leading process validation activities in medical device manufacturing.
- Experience with statistical techniques (e.g., DOE, SPC).
- Experience with Lean manufacturing techniques, value stream mapping, and continuous improvement methodologies.
- Solid communication skills.
- Solid knowledge of GMP, ISO regulations.
- Demonstrated success in leading mfg technology transfer projects to global operations.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
- Ability to work effectively within a team in a fast-paced changing environment.
- Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
- Multi-tasks, prioritizes, and meets deadlines in a timely manner.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- Ability to travel approximately, including internationally.
- Medical device experience with bioprosthetic heart valve tissue development or manufacturing or other implantable device development strongly preferred.
- Previous Development Quality Engineering experience.
- ASQ CQE or other certifications.
