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), Franklin Lakes) - 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
Quals--
• 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. •
Last updated on Apr 11, 2018