Senior Quality Engineer Resume NC - Hire IT People

TECHNICAL SKILLS

Strong technical background, especially in relation to quality control inspection and metrology equipment, radiopharmaceutical production and medical devices, diagnostic equipment, and experimental and laboratory equipment.
cGMP techniques and experience wif USP and Ph. Eur. compliance, ISO 13485, ISO 14644, and 21 CFR parts 11, 211, 212, and 820.
Excellent communication skills and technical writing ability.
Troubleshooting, Job Safety Analysis (JSA), Root Cause Analysis (RCA), Failure Mode and TEMPEffects Analysis (FMEA), Corrective and Preventative Action (CAPA), experience wif Quality Management Systems (QMS) - both mature and developing systems. installation/operation/performance qualification (IQ/OQ/PQ), and Reliability Centered Maintenance (RCM).
Lean Manufacturing.
Project planning and execution.
Familiarity wif technical and mechanical drawings; Geometric Dimensioning and Tolerancing (GD&T).
Self-starter, motivated, and capable of assuming significant responsibilities
Communication and interpersonal skills in customer-facing, training, technical, and leadership roles.

PROFESSIONAL EXPERIENCE

Senior Quality Engineer

Confidential, NC

Responsibilities:

Equipment Verification and Validation (V&V) and equipment qualification activities (IQ/OQ/PQ), test method validations, and software validations.
Development of test methods.
Tiger Team Lead for test and inspection equipment.
Tracking quality metrics and providing dashboards and visual aids for management review board.
Complaint investigations.
Corrective and Preventative Actions. Defect disposition recommendations.
Key responsible person for metrology equipment: CT Scanner, Coordinate Measurement Machines (CMMs), vision systems, etc.
Documentation responsibilities including creation, revision, and collaboration of QMS documents in a business enterprise system environment.
Responsible for SOPs, instruction documents, and quality plans.
Undertaking scrap reduction and other cost saving initiatives.
Product disposition decisions and recommendations.

Service & Support Engineer

Confidential

Responsibilities:

Independently developed documentation, maintenance manuals, and SOPs. Instrumental in teh implementation and creation of a quality system and support documents for submission to worldwide regulatory bodies for products in development.
Independently responsible for teh management of a pre-clinical facility for teh production radiopharmaceuticals.
Planned Preventative Maintenance (PM) schedule, wrote entire Technical Service Manual, and cGMP SOP documents in an ISO 13485 environment.
Prominent role in software auditing for products in development.
Supported maintenance, testing, and commissioning efforts at clinical and pre-clinical sites overseas. Domestic and international field service.
Acted in customer facing roles in a training and technical capacity.

Cyclotron/Maintenance Engineer (Phys/Accel II)

Confidential East Lansing, MI

Responsibilities:

Responsible for designing and leading upgrade and repair projects of increasing complexity, which included leading teams from several disciplines and departments.
Key resource for reducing unscheduled down time and increasing equipment reliability. Team leader for several complex emergency repairs. Key resource for round-teh-clock support for several critical systems.
Designated Operator in Charge of facility, as well as Vault Coordinator for largest vault in facility.
Liaison between visiting experimenters, laboratory management, beam coordinator, and vault coordinators.