MUST-HAVES
- Bachelor's degree or higher (engineering/science)
- 3+ yrs quality engineering w/ 1+ yrs 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
- Exp with Critical to Quality Attributes (CTQ) - tolerances on drawings
NICE-TO-HAVES
- Gage R&R, CMM (Coordinate Measurement Machine)
- Understanding of measurements methods
DESCRIPTION OF DUTIES
The Sr. Quality Engineer will ensure high level of compliance to FDA QSR/cGMPs and ISO 13485 in all assigned areas.
Responsibilities include:
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.).
QEs in Operations will also:
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.
MORE INFORMATION
RELOCATION Up to $10,000
SALARY RANGE $60,000 - $75,000
PERFORMANCE BONUS $0 - $5,000, Bonus Plan