Quality Engineer - Relocation Assistance Provided
Company: Innovative Health LLC
Location: Scottsdale
Posted on: March 20, 2023
Job Description:
The Quality Engineer will ensure compliance to required
standards including FDA and ISO during process development and the
manufacturing of medical device components. In addition, this
person will have responsibility for identifying and driving
improvements related to quality, compliance to regulatory
requirements and business efficiencies within the Quality
Organization.
- Supports the Corrective and Preventive Actions Program by
monitoring the system and completing investigations and
implementing actions as applicable.
- Supports Calibration and Preventative Maintenance
systems
- Represents and provides quality support for new product
development initiatives.
- Verifies and validates design and processes utilizing IQ, OQ,
and PQ process.
- Develops and writes test methods.
- Creates documentation for manufacturing, quality control, and
final release processes.
- Generates formal test protocols and reports.
- Supports continuous process improvements through detailed data
analysis.
- Provides documentation and support for the submission of FDA
510Ks.
- Participates in risk management activities for product and
process design projects including PFMEA risk assessments.
- Reviews and approves complaint investigations.
- Conduct data analysis using Minitab or equivalent statistical
software.
- Train manufacturing/QC personnel as needed on test methods or
manufacturing processes.
- Document test results per GDP, ISO and FDA
requirements.
- Participates in process improvement projects to reduce
costs.
- Assists with environmental monitoring of production facilities
and equipment.
- All other duties, as assigned.
Education and Qualifications:
- Minimum of Bachelor's degree in technical field (i.e.
Bioengineering, Electrical Engineering, Mechanical Engineering or
other technical field) and minimum of three (3) years
experience.
- Ability to work in a fast paced, collaborative team
environment
- Ability to handle multiple projects and coordinate cross
functional teams
- Ability to communicate effectively with management, peers and
external vendors
- Knowledge of Medical Device QMS requirements and regulatory
requirements including but not limited to FDA CFR 21 820 and ISO
13485.
- Knowledge of risk management and risk analysis methods
- Ability to write technical documents (procedures, test methods,
protocols and reports)
- Ability to conduct data analysis using Minitab
- Ability to recommend technical solutions
- Ability to specify requirements for products and
equipment
- Ability to train other
engineers/manufacturing/QC/technicians
- Ability to work with little supervision
- Ability to use personal computers including software such as:
Word, PowerPoint, Excel, Project and Minitab
- Self-starter and highly motivated
Keywords: Innovative Health LLC, Scottsdale , Quality Engineer - Relocation Assistance Provided, Engineering , Scottsdale, Arizona
Didn't find what you're looking for? Search again!
Loading more jobs...