Sr. Quality Engineer

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

Apply online by clicking on green label "I am Interested" 

or call if you have any question however applying online is the best way to apply. 

US #  571-403-0435 

India # 9999 883 470