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.
The Sr. Quality Engineer is responsible for providing primary quality engineering support in design, development, and commercialization of medical device products. Excellent interpersonal and communication skills, as well as the ability to manager across function, and multidisciplinary projects are key to be successful in this role.
About the Role…
- 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;
- Manage the execution of the risk management process, and post market surveillance/feedback review and updates on product development teams;
- 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 or product complaints and/or safety issues;
- Author CAPAs when problems are detected through various channels, including customer complaints, internal sources, or KPIs;
- Participate in the Internal Audit program as lead auditor on assigned audits.
- Provide quality engineering support to manufacturing operations;
- Maintain compliance and continuously improve the Quality Management Systems including ISO 13485, 21 CFR and other applicable regulatory requirements;
- Maintain a working knowledge or government and industry quality assurance regulations and standards for all markets where the product is distributed to;
- Perform other duties as required.
About Your Work Experience….
- 3-10 years hands-on working knowledge of the FDA QSR and ISO 13485 is required;
- Experience in design controls, risk management, and risk assessment techniques, such as FMEA, fault tree analysis, 5 Why’s, Fishbone analysis, etc.
- Experience with test methods and standards for the design, verification, and validation of medical device products;
- Highly skilled in statistical methods, gage R&R, statistical process control, sampling plans, and design of experiments.
About your education and competencies….
- Bachelor’s degree in science or engineering is preferred;
- Proficiency using the Microsoft Office Suite including Outlook, Excel, Word, PowerPoint, and Visio;
- Experience in the FDA-regulated medical device industry is required.
- CQA and CQE desired.
- Must be self-motivated, and possess strong organizational skills, and outstanding written and verbal communication skills;
- Possess a positive, team-player attitude;
- Must be able to multi-task, meet tight deadlines, and prioritize changing demands in a fast-paced, entrepreneurial environment;
- Requires high accuracy, thoroughness, and attention to detail in reviewing and completing quality records.
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, most creative, and patient-focused people you will have ever worked with. We are looking for employees who have a passion and hunger to use their educational and professional experiences to achieve our mission. The stakes are high, and we are working a green field of opportunity to bring about seismic change.
If this appeals to you, we also offer comprehensive Health-care benefits including Medical, Dental and Vision insurance, a 401K retirement plan, Life and disability insurance and 3 weeks’ vacation to start.
You must be able to provide proof of authorization to work in the United States as a condition of employment.
Hemanext requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, the candidate must be able to provide proof of full vaccination, or request an exemption due to a medical reason, a sincerely held religious belief or practice, or pregnancy, as of the first day of work, to be considered for this position.
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.
To Apply → Please send your resume to firstname.lastname@example.org or apply through Linkedin.com.