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

• 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

Additional Information

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