Sr. Operations Quality Engineer
Position Description:
Sr. Operations Quality Engineer, Covidien LP (a Medtronic company), Irvine, CA. Multiple positions
available. Provides quality engineering support to ensure the successful
development of Medtronic Neurovascular products. Ensure design control
requirements are met and products are developed and manufactured in accordance
with applicable industry standards, regulatory requirements and customer
requirements. Works with vascular devices, embolic coils, stents, catheters,
balloons, aspiration devices, coatings and guide wires to ensure quality
products. Navigates various government and industry standards to include FDA
21CFR part 820, ISO13485, ISO14971 and Good Manufacturing Practices (GMP). Coordinates risk activities using PFMECA and
DFMECA and other risk management tools. Provides Process Verification &
Validation for product quality, including development and execution of
protocols (IQ, OQ, PQ) and test methods (TMV). Coordinates root cause
investigations using various quality tools (5 Whys, 6 M, Ishikawa Diagram,
Pareto Charts). Utilizes lean six sigma and lean principles to make
manufacturing and efficiency improvements including DOE (Design of
Experiment). Participates in and leads
CAPA and NCMR root cause investigation/determination and implementation of
corrective and preventive actions as necessary. Utilizes statistical analysis
tools including process capability and measurement system analysis, and
tolerance interval analysis with proficiency in Minitab. Designs and
manufactures documentation to include specifications, procedures and sampling methods
as well as being proficient in engineering drawing and GD&T. Shift support
may vary.
Basic Qualifications:
Master’s degree in
Biomedical Engineering, Mechanical Engineering, Industrial Engineering,
Industrial Engineering Management or related field and two (2) years of
experience in medical device quality engineering. Must possess at least 2
years’ experience with each of the following: FDA 21CFR part 820, ISO13485,
ISO14971, and Good Manufacturing Practices (GMP); Risk activities using DFMECA and
PFMECA and risk management tools; Process Verification & Validation;
development and execution of validation protocols including Installation
Qualification (IQ), Operational Qualification (OQ), and Performance
Qualification (PQ); Test method development and validation (TMV); Root cause
investigations using various quality tools including 5 Whys, 6 M, Ishikawa
Diagram, and Pareto Charts; Six sigma and lean principles including DOE (Design
of Experiment); CAPA (corrective and preventive actions) and NCMR (non-conforming
material report) investigation and corrective action implementation;
statistical analysis tools including process capability and measurement system
analysis, and tolerance interval analysis with proficiency in Minitab; design
and manufacturing documentation to include specifications, procedures and
sampling methods; and engineering drawing and GD&T. Shift support may vary.
