Job description
Lexington Medical is a Boston based medical device manufacturer that produces a proprietary, minimally invasive surgical stapling solution. We are one of the fastest growing medical device companies in the industry, growing our revenue exponentially since our product was launched. Our enhanced capabilities and design approach allow us to be nimble and responsive to market dynamics, while enabling us to work closely with leading physicians to bring a unique range of devices best suited for patients’ needs.
Our recruiting philosophy is centered on hiring highly talented individuals committed to delivering innovation to health care providers and their patients. We focus on creating a culture that fosters continuous growth as an individual and within the organization. With our continued success, our team has grown organically at a rapid rate, and we have an aggressive hiring plan forecasted over the next few years. By joining our team at Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide.
As a Quality Engineer at Lexington Medical, you will drive quality system and design assurance activities and play a key role in creating a world-class quality management system and building a quality function that is core to the company’s success.
Our ideal candidate will embrace working in a fast-paced, entrepreneurial, and collaborative environment; be a self-starter, independent, results-oriented team player with a demonstrated ability to manage multiple projects and deadlines including shifting priorities. If you enjoy wearing multiple hats and are looking to make an immediate impact at a fast-growing company, this might be exactly the opportunity you’ve been looking for!
What you will do:
- Drive new product development and risk management activities in accordance with US and international standards.
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Drive continuous improvement and CAPA projects, and proactively identify and implement best-in-class quality engineering practices.
- Develop test methods and inspection procedures and implement process control systems to support the development, qualification, and on-going manufacturing of products.
- Support supplier quality management, including conducting sub-contractors and component supplier audits.
- Proactively investigate and analyze customer complaints, and oversee problem reporting to regulatory agencies.
- Coach and develop team members and supervise/train quality technicians.
Requirements:
- BS in Engineering (Biomedical, Mechanical, Industrial, Operations), top-tiered institution with excellent GPA.
- Experience developing and implementing quality management systems.
- Exceptional working knowledge of US and international medical device regulations.
- Experience in new product development (NPD) and production transfer
- Experience in applying systematic problem-solving techniques and defect avoidance methodologies
- Strong team orientation and ability to lead in a cross-functional environment
- 4+ years of work experience. Exceptional candidates with less experience will be considered.
- CQE or equivalent certifications a plus
- Clean room and/or microbiology experience a plus
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