Quality Engineering Senior

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

NICE-TO-HAVES

Gage R&R, CMM (Coordinate Measurement Machine)

Understanding of measurement methods

Responsibilities

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.

More Information

Relocation allowance up to $10,000

Salary range: $60,000 - $75,000

Performance bonus: $0 - $5,000

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