Sr Quality Engineer, Capital Equipment
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Job Location:
Campbell, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Location: This position is based in our Campbell California offices. This position is full time.
Why Imperative Care
Do you want to make a real impact on patients Imperative Care is changing the way stroke is part of our team youd be developing breakthroughs that will revolutionize the future of stroke care. Every day the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient and they come first in everything we do.
What Youll Do
As a senior professional in this field this position will use solid knowledge and experience and contribute to the development manufacture and distribution of Imperative Cares medical device products by applying Quality Engineering principles to all applicable processes and procedures in accordance with the Companys Quality Policy and Quality Objectives.
- Provide quality support for medical device R&D and manufacturing activities throughout all phases of the product development process (e.g. requirement development specification development verification and validation testing design transfer risk assessment usability design change control).
- Participate and contribute to the development of product design history file and ensure compliance to internal processes and external standards and regulations.
- Collaborates with team members to define requirements specifications testing and component/product acceptance activities.
- Participate in risk management process ensuring that all the risks were properly identified/assessed and update risk management files accordingly.
- Direct interaction with suppliers to qualify and maintain approved supplier status as well as oversee supplier process validation activities. May be required to evaluate supplier notification of change and recommend necessary actions to maintain compliance
What Youll Bring
- Bachelors degree in related field (science industrial operations mechanical biomedical or electrical engineering) and a minimum of 5 years work experience in the medical device or related regulated industry experience; or equivalent combination of education and work experience
- Experience working with electro-mechanical medical device robotics or medical software is highly desired.
- Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820 ISO ; IEC 60601-1 IEC 62304 medical device software cybersecurity and related regulations
- Experience addressing supplier or process issues (CAPAs NCMR/NCRs SCARs etc.)
Join Us! Apply Today.
Salary Range: $/annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position candidates work experience education/training key skills and internal equity as well as location market and business considerations when extending an offer.
The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.
Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.
Required Experience:
Senior IC
Key Skills
- Food Safety
- LAN
- Accomodation
- Instrumentation Engineering
- AC Maintenance
- Client Services
About Company
Accelerating the development of life-changing technologies to bring more care to more patients suffering from stroke and other devastating vascular diseases.
