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Quality Systems Auditor - Medical Devices

Company:
LanceSoft INC
Location:
Franklin Lakes, New Jersey, 07417, United States
Posted:
December 05, 2016
Description:

Qualifications:

• Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, Canadian MDR. • In-depth understanding of the application of quality systems to the medical device industry. • Industry recognized certification in a Quality System element specialty (e.g. ASQ Certified Quality Auditor, Quality Engineer) preferred. • Supplier auditing experience required. • TrackWise, technical writing experience preferred. • Prior experience managing external regulatory audits preferred. • Excellent communication skills at all levels both written and verbal. • Ability to perform multiple tasks and prioritize work load. • Effective analytical, technical, and problem solving skills. • Effective meeting and presentation skills. • Self-motivated /directed.

Responsibilities:

The Quality Systems Auditor is accountable for the tracking and execution of quality systems audits. This position will help drive the implementation of a standardized quality system process for supplier management, as well as facilitate the development and execution of the supplier audit plan for MPS integration. • Consistent application of Quality system standards to assigned Quality system area • Develops solutions to routine assigned activities of moderate scope & complexity • Follows applicable Company / Unit procedures and may make updates to procedures and policies • Works within and across functions for assigned Quality systems • Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements • Subject Matter expert / Super User at site for assigned quality system • Guides the successful completion of major programs and may function in a project leadership role Position specific responsibilities include support of the following, however are not limited to: • Quality Systems (Medication & Procedural Solutions (MPS),) - Supplier Audits: Performs audits of MPS suppliers Coordinates execution of the supplier management integration plan to ensure execution of all required audits as well as timely implementation of corrective actions and closure of audits - General: Develops training content and provides quality systems related training at unit and Plant locations Maintains and improves the Franklin Lakes and WW Quality System documentation Tracks integration project progress and provides periodic reports

Comments/Special Instructions

Candidates should possess a minimum of 5 years experience performing supplier audits for the medical device industry.