21 NPD Quality Engineer (QE) Jobs in Draper, UT
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NPD Quality Engineer (QE)
$93k-110k (estimate)
Full Time | Retail
3 Weeks Ago
Planet Pharma is Hiring a NPD Quality Engineer (QE) Near Draper, UT
Job DescriptionTarget PR Range: 32-42/hr
Key Responsibilities
- Depending on experience
Key Responsibilities
- Apply knowledge of quality engineering principles and methods to ensure compliance with Quality System and also Regulatory requirements. Focus on design control, design verification/validation, FMEA, specification development, statistical reliability, critical to quality/process control, acceptance sampling, and inspection/test methodologies
- Provide assistance to subject matter experts (SME) for responsible product/project within the overall manufacturing and processing of pericardial tissue heart valve assembly, including leveraging of key knowledge of quality engineering principles
- Review design changes; partner with R&D in the design of safe and effective THV devices; partner with Manufacturing Engineering to develop critical manufacturing processes and provide technical quality engineering support for pilot production of clinical devices
- Optimize manufacturing processes using engineering methods (e.g., Six Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
- Develop basic experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and lead team members to drive project completion
- Investigate basic manufacturing product quality and compliance issues (e.g. CAPA, NCR, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
- Identify opportunities for design and/or manufacturing transformation in a manner that ensures product development continues to evolve and improve
- Assist with developing technical content of risk management files
- Assist with developing training and documentation materials for production (e.g., inspection documents) to enable the seamless knowledge transfer of project and manufacturing processes from NPD to Operations
- Bachelors or Masters degree in Engineering or Scientific field
- Engineering degree
- Engineering/Internship experience within a medical device industry or highly regulated environment
- Quality Engineering experience in New Product Development.
- Experience providing support for either Design Assurance, Design Controls, Verification & Validation, and/or Test Method Development
- Class III new product development experience
- Knowledge of and experience with Risk Management (i.e. dFMEAs and/or pFMEAs), and reviewing or updating risk management documents.
- Knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)
Job Summary
JOB TYPE
Full Time
INDUSTRY
Retail
SALARY
$93k-110k (estimate)
POST DATE
06/06/2024
EXPIRATION DATE
07/03/2024
WEBSITE
planet-pharma.com
HEADQUARTERS
TRIKKANDIYUR, KERALA
SIZE
100 - 200
REVENUE
<$5M
INDUSTRY
Retail
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