Senior Quality Engineer
3 weeks ago
- Own, build and implement a Quality Management System for a newly commercialized product and research and development
- Own the development and implementation of standard operating procedures and processes to meet ISO 9001 requirements
- Identify process gaps, develop and implement quality plans and monitor progress towards quality goals and objectives
- Lead root cause investigations for product failure or variation in the process and provide quantifiable results
- Identify and implement engineering solutions for actions resulting from root cause investigations
- Support team in process improvements and incorporate statistical thinking
- Lead team in continuous improvement initiatives and drive efforts related to improving product quality and minimizing process variation
- Present findings to all levels of leadership providing recommendations and solutions
- Perform internal quality audits and work with 3rd party auditors to ensure conformance with established procedures and processes
- Effectively achieves corrective action through proven problem-solving techniques to provide ongoing feedback for quality improvement
- Develop and maintain effective working relationships with local and global partners
- Stay current with quality advancements in industry and introduce new perspectivesMinimum Qualifications:
- Bachelor's degree in engineering (Chemical, Material Science, Manufacturing, Mechanical or Industrial)
- 5+ years of experience in a manufacturing or product development environment directly involved with quality, or equivalent combination of education and experience.
- Experience in regulated quality management system
- Advanced computer literacy skills, Proficient in Minitab, JMP or similar statistical analysis software
- Demonstrated ability to lead cross functional teams, developing common processes and driving standardized practicesPreferred Qualifications:
- Manufacturing and/or product development experience, including SPC, DOE, FMEA, and DMAIC problem solving
- Strong organizational skills and attention to detail
- Ability to recognize problems/opportunities and recommend/implement solutions
- Ability to manage multiple projects simultaneouslyKey words: GMP, QMS, Quality Management System, Minitab, JMP, ISO 9001Employment opportunities for positions in the United States may require use of information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
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