MUST-HAVES
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
Job details are sourced from the employer's original posting.
Open job postingAbout the company
The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance. Choose Workila, and make delivering innovative work part of your extraordinary career.