The employees at Hemanext are committed to continuing the effort of the transfusion medicine community to save lives and improve patient outcomes. Our distinctive focus is on innovations systems enabling blood collection, processing, storage and transfusion that will promote radical improvement in the quality, safety, efficacy and cost of transfusion therapies.
Our team is seeking an experienced, collaborative, and creative Quality Engineer to join our team in Lexington, MA. The Quality Engineer will a key role within the Operations group and has responsibility to provide quality engineering support in design, development, and commercialization of medical device products. The successful candidate will participate on cross-functional teams within the company as part of the introduction of new products. This is a hybrid position requiring 3 days hands-on, on-site work/2 days remote. The position involves working in a fast-paced, results-oriented team environment and will be vital to the expected growth and success of our company.
Key Areas of Responsibility
- Facilitate the application of design controls through all phases of the product development process, including ensuring conformance of Design History Files to applicable requirements and regulatory standards.
- Assist in management of the risk management process, and post market surveillance/feedback review and updates.
- Review design development, and design change documents to ensure that all documentation includes the necessary justifications, validation and verification updates, risk assessment, etc.
- Provide support for product complaint investigations and ensure rapid resolution of product complaints and/or safety issues;
- Author CAPAs when problems are detected through various channels, including customer complaints, internal sources, or KPls
- Maintain compliance and continuously improve the Quality Management Systems in regard to ISO 13485, 21 CFR and other applicable regulatory requirements.
- Provide quality engineering support to Operations.
Education and Experience Requirements
- A Bachelor of Science in Science or Engineering or a life science degree is preferred
- Minimum five (5) years of working knowledge of the FDA QSR and ISO 13485 is required
- Experience in the FDA-regulated medical device industry is required
- Experience working in a highly regulated environment
- Must be able to work in a fast paced, hands-on environment
- Must possess exceptional interpersonal and communication skills and the ability to perform effectively in a team environment
What Hemanext offers you…
Hemanext is a pre-revenue company founded on a decade of scientific research and innovation and dedicated to bringing advancements in the world of transfusion therapy, and by doing so, dramatically impacting the patient’s quality of life. We want to create what has never been done before for some of our sickest patients.
You will be working alongside some of the brightest, hardworking and patient-focused people you will have ever worked with. We are looking for employees who have a passion to use their experiences to achieve our mission.
If this appeals to you we offer Medical, Dental and Vision insurance, a 401K retirement plan, Life and disability insurance, on-site gym, and up to 3 weeks paid time off.
You must be able to provide proof of authorization to work in the United States as a condition of employment.
Hemanext is a smoke-free, alcohol-free and drug-free work environment. Hemanext is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Hemanext will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
How to apply
To Apply → Please send your resume to email@example.com.