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Sr. Quality Engineer
Job in
Fort Lauderdale, Broward County, Florida, 33336, USA
Listed on 2026-06-27
Listing for:
Workila
Full Time
position Listed on 2026-06-27
Job specializations:
-
Engineering
Quality Engineering, Process Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Job Description
The Sr. Quality Engineer will ensure a high level of compliance to FDA QSR/cGMPs and ISO 13485 in all assigned areas.
MUST-HAVES- Bachelor's degree or higher (engineering/science)
- 3+ years quality engineering with 1+ year Med device industry
- Know GD&T, Solidworks (read drawings), root cause analysis and CAPA
- Can move NC from beginning to end, can come up with solutions
- Experience with Critical to Quality Attributes (CTQ) - tolerances on drawings
- Gage R&R, CMM (Coordinate Measurement Machine)
- Understanding of measurement methods
- Work closely with internal departments (Operations, Advanced Operations, R&D, and Distribution) to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-proofing, etc.).
- Lead the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, regulatory actions, etc. Lead and/or support CAPA investigations and related corrective and preventive actions.
- Lead continuous improvement activities such as Quality Circles, Process Capability.
- Support Lean environment and re-work/scrap reduction.
- Participate in the development and improvement of manufacturing, distribution and/or other processes for existing and new products.
- Participate on project teams with internal departments to support product and/or process design and development activities.
- Develop, review and improve inspection plans, routers and product drawings.
- Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
- Interface with suppliers for new processes, quality issues and process improvements for assigned projects.
- Support product transfers to other plants/facilities.
- Lead or participate in implementation of Process Management activities (pFMEA and control plans) within assigned client groups.
- Review/approve product and/or process change control documentation and specifications.
- Participate in continuous (breakthrough) improvement activity and process re-engineering projects.
- Relocation allowance up to $10,000
- Salary range: $60,000 – $75,000
- Performance bonus: $0 – $5,000
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