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 role of Senior Quality Engineering Manager has responsibility for providing primary Quality Assurance and Quality Control functions support at the Hemanext facility in Avon, MA, working closely with the Hemanext Inc. headquarters located in Lexington, MA. Excellent interpersonal and communication skills, as well as the ability to manage across function, and multidisciplinary projects within FDA validation are key to be successful in this role. This position is based in Avon, MA. This is a hybrid position requiring a 3 days on-site /2 days remote work schedule.
Key Areas of Responsibility:
- Direct/ manage/ supervise the quality control function/ team in Avon to ensure products and processes are compliant to internal standard operating procedures and external requirements.
- Oversee incoming inspection activities, ensuring incoming inspection criteria are defined and documented. Develop and document inspection and testing methods for incoming, in process and finish product acceptance activities.
- Administer Nonconforming Material process and serve as the MRB chairperson.
- Investigate quality issues arising from supplier and manufacturing operations, identify root causes and recommend appropriate corrective action.
- Assist with Product and Process Corrective Actions investigations and resolutions, monitor actions taken and perform effectiveness checks.
Education and Experience Requirements
- Bachelor’s degree in science or engineering is preferred.
- CQA and CQE desired
- 5 years minimum hands-on working knowledge of the FDA QSR and ISO 13485 is required;
- 5 years’ experience managing a Quality team, hiring, performance management, objective setting and all other areas of staff management and leadership is required.
- Experience in managing nonconforming process, CAPA process, Incoming inspection process and risk assessment techniques, such as FMEA, fault tree analysis, 5 Why’s, Fishbone analysis.
- Experience with test methods and standards for the design, verification, and validation of medical device products.
- Experience in the FDA-regulated medical device industry is required
- Experience working in a highly regulated environment
- Skilled in statistical methods, gage R&R, statistical process control, sampling plans, and design of experiments.
- Proficiency using the Microsoft Office Suite including Outlook, Excel, Word, PowerPoint, and Visio is required.
- Must be self-motivated and able to multi-task, meet tight deadlines and prioritize changing demands in a fast-paced, entrepreneurial environment.
What Hemanext offers you…
Hemanext is a pre-commercial 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, Stock options, a 401K retirement plan, Life and disability insurance and 3 weeks’ vacation to start, your birthday off and a week of shutdown at the holidays.
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.
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