Quality Engineer
Quality Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
About Scientia Vascular:
Our mission is to save lives.Scientia Vascular is a leading innovator and manufacturer of endovascularmedical devices. We use micromachining and microfabrication processes tomanufacture products that provide physicians with enhanced performance for optimaloutcomes for their patients.
Quality Engineer Job Description:
This position assures that new product designs and the processes for manufacturing them meet all requirements with respect to safety and efficacy. This individual will be an active on new product development and ongoing manufacturing activities.
Primary Responsibilities:
- Provide Technical guidance to Quality Engineers Quality Technicians and Inspectors.
- Development of Test Protocols and Final Report to support Regulatory 510K PMA CE mark and International registrations.
- Support PreConcept Front End Product Innovation Process activities for new technologies.
- Lead Quality Engineering Projects to improve Quality systems and Procedures.
- Assist with the development of the Design Validation Protocol and the subsequent Design Validation Report including an analysis of all data and a decision on design acceptability.
- Provide input into the project Failure Modes and Effects Analysis Device Master Record Risk Analysis Risk Benefit Risk Management Plan and Risk Management Report for the product development process.
- Determine the degree of Biocompatibility testing required as per ISO10993 and company procedures. Coordinate the testing at an outside lab and document results.
- Develop or assist in development of inspection and test methods per product specifications.
- Assist in the development test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating.
- Develop and document the Quality Management System for the manufacture of new products including Inspection Plans for the inspection of components subassemblies and final product.
- Support the development of the PFMEA.
- Perform and/or Support Process Development Studies to determine the acceptability of new processes or equipment.
- Design and qualify inspection test methods and equipment.
- Support Process Transfers to the Production facilities.
- Conduct investigations of rejected nonconforming components and products; conduct NCR action when required.
- Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering.
- Provide technical support to resolve quality problems in development pilot manufacturing or with suppliers as warranted.
- Other duties as assigned with or without accommodation.
Requirements:
- Bachelors or Master of Science Degree in Engineering or Technical Sciences or equivalent work experience and/or professional qualifications.
- Experience with Quality in a manufacturing environment.
- Knowledge and experience with advanced quality systems concepts regulatory compliance requirements and applied statistical concepts.
- Demonstrated knowledge of interpretation and application of QSR MDD ISO 13485 and other international standards.
- Good oral and written communication skills
Key benefits we provide:
- Medical Dental Vision insurance
- Generous Paid Time Off (PTO)
- Paid Parental Leave
- Paid Holidays
- 401k Plan (with a generous employer match)
- Life Insurance (company paid)
- ShortTerm & LongTerm Disability Insurance (company paid)
- Subscription to Calm
- Employee Assistance Program
- An environment of belonging where everyone can thrive
Commitment to Equal Opportunity:
The Scientia Vascular culture iscentered on the principals of equal opportunity for all employees. Consistentwith our culture all qualified applicants will receive consideration foremployment without regard to race color religion gender gender identity orexpression family status marital status sexual orientation national origingenetics disability age or veteran status or any other nonmerit based orlegally protected grounds.
Visit our website and learn moreabout us atwww.scientiavascular.
Employment Type
Full Time
