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 Quality Inspector provides Quality Control functions to support Hemanext’s manufacturing facility in Avon, MA. It may also support inspection activities for new engineering/development projects from Hemanext’s Lexington, MA facility.
Key Areas of Responsibility:
- Performs Incoming Inspection, including documentation review, measurements and testing as applicable.
- Performs first article inspection of components procured from suppliers, including prototype materials if requested by product development.
- Initiates reports and supports investigation of non-conforming materials.
- Maintains incoming inspection files and Device History File.
- Performs first article label inspection prior to manufacturing runs.
- Performs in process inspections.
- Conduct production documentation review and production lot release.
- Supports all third-party inspections and audits (NB, FDA, etc.)
Behavioral and Interpersonal:
- Must be self-motivated, possess good organizational skills, and written and verbal communication skills;
- Detail oriented
- A cooperative positive attitude is a must;
- Must be able to multi-task, meet tight deadlines and prioritize changing demands in a fast-paced, entrepreneurial environment
- The position will interact with manufacturing and product development within the organization.
- May interact with suppliers
Education and Experience Requirements:
- Associate degree preferred with 2-6 years of related experience, or 4-8 years of related experience
- Proficient in English with good comprehension of written procedures and instructions
- Experience in the FDA-regulated medical device industry is required
- Proficient using the Microsoft Office Suite including Outlook, Excel, Word, Powerpoint,
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, and 3 weeks vacation to start, and an on-site gym.
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.