Quality EngineerKatalyst Healthcares and Life Sciences • Carlsbad, CA, United States

Quality Engineer

Katalyst Healthcares and Life Sciences • Carlsbad, CA, United States

2 days ago

Job type

Full-time

Job description

Responsibilities :

Participate in Suppliers' and contract manufacturers' performance scorecards as required.
Coordination and execution of QMS audits (Internal and Vendor) as required.

ct as Quality representation for product innovation processes as directed by the Quality Director.

Coordinate the calibration and preventive maintenance processes of the measurement devices in all client sites.

Manage all Quality Management system activities including CAPA, Management Review, and Document Control.

Conduct failure analysis on returned products.

Support client WH and VAS centre regarding work instructions and process definition.

Other duties as assigned.

Requirements :

Minimum 5 years of working experience as a Quality Engineer in a manufacturing environment.

Experience in ISO Quality Systems Implementation and Management.

Bachelor's degree or equivalent work experience in a Manufacturing environment.

Strong knowledge of MS Excel and skills in other Microsoft applications (i.e. Word, PPT, etc.)

ISO Led auditor / Auditor certified preferred.

ISO 9001 Quality System Managements.

PPAP, FMEA, SPC, Lean-Six Sigma methodologies.

Strong analytical skills to identify the source of problems and to propose solutions.

Strong organizational and communication skills.

bility to multi-task and meet deadlines.

Demonstrated time management skills.

Strong attention to detail.

Positive attitude, self-motivated and eager to succeed.

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Quality Engineer • Carlsbad, CA, United States

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