Quality Engineer - Design
Company: DPS Group Global
Posted on: November 12, 2021
Position summary:DPS Group Global is seeking a Design Quality
Engineer to support our medical device client in the Auburn, AL
area. The Design Quality Engineer will be working with a New
Product Introduction team to support Design and Development. (This
opportunity is not remote and will be full-time at the client site)
- Updating the User requirements based on market/field
applications feedback for new product (not a line extension).
- Generating the Design input based on #1 and subsequently
support the creation of Design Outputs (working with Engineering,
- Evaluate Risk Management (per ISO 14971) on product risks -
align with #4 and process Risk.
- Overseeing the Design Test Matrix (Verification and Validation)
- generate protocols for V&V.
- Attend Design Reviews and provide input.
- Build Design History File based on 1-5.
- Coach / mentor other team members in the use of Design controls
where appropriate. Education & experience:
- Bachelor's degree in engineering, equivalent degree, or
extensive work experience.
- The individual has to be able to provide real-world application
experience and examples rather than identify a procedure for others
to review and "figure it out".
- Plastics background would be helpful.
- Familiar with and understand recognized regulations and
standards such as (where applicable): 21 CFR Part 820 (FDA QSR,
cGMP), ISO 13485 Medical Devices - Quality Management Systems, ISO
14971 Risk Management, ISO 9001 Quality Management Systems
(preferred). The CompanyDPS Group is a global EPCM firm offering
full-service solutions within the Life Sciences (pharmaceutical,
biotechnology, and medical technology) and Advanced Technology
(semiconductor, data center, and solar) industries. DPS is
dedicated to delivering successful projects with a 'client-first'
mentality and personal touch across a range of market sectors:
Project and Program Management, Procurement, Design, Construction
Management, Health and Safety Management, Commissioning,
Qualification, and Start-up. DPS Engineering Inc. is an Equal
Opportunity Employer and employment selection decisions are based
on merit, qualifications, and abilities. DPS does not discriminate
in employment opportunities or practices on the basis of: race,
color, religion, gender, national origin, age, sexual orientation,
gender identity, disability, veteran status or any other
characteristic protected by country, regional or local law.
Keywords: DPS Group Global, Auburn , Quality Engineer - Design, Engineering , Auburn, Alabama
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