Sr Quality Engineer
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Job Location:
Campbell, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
01-11-2025
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 input to define required validations necessary to support significant process changes on commercially launched products.
- Collaborate with team members to define validation requirements specifications testing and component/product acceptance activities.
- Analyse data by completing hypothesis normal distribution and process capability analysis tests intended to provide input on the quality of the product/process being evaluated/monitored.
- Create and revise quality assurance procedures as required to maintain compliance to changing regulations and guidance documents.
- Train broad audience on the use of procedures to comply with Quality Systems and Regulations.
- Serve as liaison with laboratories conducting routine product testing or root cause analysis related to testing failures or deviations.
- Conduct methodical root cause investigations and provide guidance to prevent recurrence.
- Work with suppliers to qualify and maintain approved supplier status. May evaluate supplier notification of change and recommend necessary actions to maintain compliance.
- Perform statistical analysis of manufacturing data and quality processes and creation of reports based on quality documentation.
- Review DCOs involving product or process changes to ensure consistency with company procedures and quality system compliance.
- Conduct and review Risk Management assessments on product and process changes.
- Conduct failure mode effect analysis on product.
- Support projects (including product enhancements) in an aggressive manner consistent with corporate objectives.
- May provide quality metric data to various functional groups within the organization.
What Youll Bring
- Bachelors degree in engineering or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and work experience
- Advanced degree and experience with catheters endovascular/neurological devices is highly desired.
- Experience addressing supplier or process issues (CAPAs NCMR/NCRs SCARs etc.).
- Demonstrated knowledge of quality system requirements (FDA 21 CFR Part 820 ISO 13485 or ISO 9001) risk management standards (ISO 14971) and good manufacturing practices.
- Excellent communications skills (both written and verbal).
- Proven ability to provide thorough and meticulous review of documents.
- Proven ability to write clear concise and well thought out technical documentation with focus on failure investigations and inspection procedures.
- Strong ability to perform multiple tasks concurrently with accuracy.
- Proficiency with Microsoft Office products.
Employee Benefits include a stake in our collective success with stock options competitive salaries a 401k plan health benefits generous PTO and a parental leave program.
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:
Manager
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Accelerating the development of life-changing technologies to bring more care to more patients suffering from stroke and other devastating vascular diseases.
