Senior Quality Management Engineer
Luminoah is seeking a highly skilled and experienced Senior Quality Management Engineer to join their dynamic team. As a Senior Quality Management Engineer, you will play a critical role in ensuring that our products and processes meet the highest standards of quality and reliability.
You will lead quality improvement initiatives, develop and implement quality management systems, and provide guidance and support to cross-functional teams.
As a Senior Quality Management Engineer, you will have the opportunity to make a significant impact on our organization’s success by ensuring that our products and processes consistently meet and exceed quality expectations.
In 2019, Luminoah’s founder, Neal Piper, and his family received a cancer diagnosis for their 3-year-old son. Neal, his family, and their care team immediately got to work. After some time, they realized that the tumor would affect his son’s ability to safely eat and drink, creating a new reality for their family.
After personally experiencing the weight of a nutritional feeding program, requiring bulky equipment, overnight feeding, and the inability to share data effectively with their physician, Neal decided to do something.
He built a team of people from some of the most successful companies in spine care, diabetes care, and software development to build the world’s first truly portable, connected tube feeding system.
- Strong knowledge of quality management systems, methodologies, and tools such as IEC 60601, Statistical Process Control, and Root Cause Analysis
- Proficiency in statistical analysis and data-driven decision making
- Excellent problem-solving and analytical skills with the ability to identify issues and implement effective solutions
- Solid understanding of FDA requirements and med-device standards
- Strong project management skills with the ability to lead cross-functional teams and drive quality improvement initiatives
- Work with and manage third-party suppliers in the creation and maintenance of a Quality Management System
- Initiate, write, and update quality system procedures to improve compliance and continual Quality System improvement
- Quality Management System assessment, updates, and maintenance
- Coordinate and follow up periodic management review meetings with senior management
- Manage all aspects of internal Quality System Audits to ensure compliance and continual improvement
- Risk Management Assessment and updates
- Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements, including establishing and maintaining applicable procedures
- Conducts supplier and internal audits and reviews, as well as analyzes data and documentation related to all types of audits
- Report on supplier performance in regard to Quality and non-conforming reports through the Supplier Scorecard program
- Administer and manage the CAPA program, including SCARs
- Regulatory reporting evaluation of complaints and complaint closures
- Administer and manage Quality System training activities and coordination
- Guide teams and individuals as needed in Quality Assurance processes and systems
- Report on quality system performance in general as it pertains to Management Review objectives
- Represent Quality Assurance in Design Control processes
- Ensure design control files (DHF, etc.) meets regulatory, and quality, and implement, maintain, and verify the change control of company documents with the document control system, ensuring availability of all quality records for review and/or audits
Experience and Qualifications
- Bachelor’s degree or 5-7 years of Quality Engineering or Assurance experience in the medical device industry
- Experience as a Manager or Supervisor position preferred, with knowledge of various quality processes and systems as well as FDA regulations, guidance, and processes
- ASQ Quality Auditor or Engineering certification preferred
Knowledge, Abilities, and Skills:
- Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job
- Ability to function in a small company, “hands-on” environment
- Strong verbal skills, including technical writing
- Knowledge of database software, inventory software, manufacturing, word processing, spreadsheet, and presentation software
- Knowledge of various quality processes and systems and ability to maintain and implement such processes and systems
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