Abiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.
Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion, and continuous development.
The Sr Quality Engineer is responsible for maintaining the Environmental, Microbiology and Sterilizations systems and practices through the implementation of the appropriate Medical Device standards. The candidate will be a subject matter expert in these areas and coordinate all related activities across the organization.
Principle Duties and Responsibilities:
- Facilitates Parts and Product Cleaning Validations, as required.
- Facilitates the implementation of Environmental Monitoring programs and risk assessments for testing.
- Collaborates to integrate all sterilization and microbiology elements to new practices per J&J.
- Facilitates the timely completion of quarterly audits, monthly Bioburden, and annual re-certification process for all sterilization modalities.
- Works closely with engineering investigation teams to assure the timely closure of technical investigations.
- Works with R&D, manufacturing, and quality to bring new product and changes to existing products to completion as the sterilization SME.
- Coordinates, monthly, quarterly, and annual environmental monitoring testing.
- Works with sterilization, environmental monitoring, and product testing vendors to resolve any non-conformances.
- Prepares metrics and trending reports for Sr. Management monthly.
- Provides direction regarding Corrective and Preventative Actions (CAPAs) that relate to the Product microbiology, sterilization, and environmental monitoring.
- Assists management on departmental projects as necessary.
- Bachelor Degree or equivalent required.
- 5+ years of related work experience desired; Medical device experience preferred.
- Knowledge of lean, six sigma, kaizen and continuous improvement initiatives a plus.
- Excellent verbal and written communication skills.
- Strong organizational skills; must be detailed-oriented.
- Ability to execute tasks in a timely manner under general supervision.
- Strong knowledge of Microsoft Office Suite and Adobe Acrobat
ABIOMED is an equal opportunity employer. We support equal opportunities for our employees regardless of ethnic origin, skin color, religion, gender, sexual orientation, gender identity, disability or nationality.