Quality Systems Specialist

Detalles de la oferta

.**Careers that Change Lives**A Day in the LifeResponsibilities may include the following and other duties may be assigned.- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.- Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.- Co-ordinates legal requests in support of government investigations or litigations.- Ensures the quality assurance programs and policies are maintained and modified regularly.- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.**Must Have: Minimum Requirements**- Bachelors degree required- Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience**Nice to Have**- Bachelor's degree in Engineering Industrial or similar- Experience minimun of 2 years relevant- Advanced Statistical Technique- Excellent English written and oral communication skills.- Strong interpersonal skills.- Knowledge of the industry regulations and ISO standards.**Preferred Requirements**:- Data analysis experience- Quality System knowledge- Two years experience within Supplier Quality- Four years experience within the medical device/pharmaceutical industry.- Experience with quality tools and process improvement techniques.- Experience with Agile database management or other IT-related skills**Essential Functions**:- Serve as a vital resource for Supplier Quality Assurance team maintaining a Global Approved Supplier List (ASL). This includes adding suppliers to the ASL per Medtronic's 019 Purchasing Controls and maintaining these suppliers to ensure compliance. Additional responsibilities are shown below.- Subject matter expert on Purchasing Controls, ASL & supplier file requirements; advises sites outside of normal responsibilities.- Qualifies suppliers according to company standards.- Resolves supplier-related problems as they occur.- Provides technical guidance and quality compliance for Supplier Quality peers.- Collaborates with site representatives to add new suppliers for new products.- Has a large Medtronic wide network to get people in touch with the right people quickly


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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