Quality Systems Specialist (Exp In Capa, Document Control, Supplier Quality&Qms) - Remote

Position : Quality Systems Specialist (Exp In CAPA, Document Control, Supplier Quality& QMS)

Location : Tempe, AZ

Duration : 8 Months

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Quality

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Work hours: 8 hr days 7-5

• 3 Must haves on the resume:

Quality Management Systems experience, Experience in at least 3 of the 5 areas (Audit, CAPA, Document Controls, Supplier Quality, Quality Panning / management review), Has experience in procedure development / alignment/ harmonization, medical device industry experience

Position Summary:

• The Quality Systems Specialist actively supports the development, implementation, and monitoring of an element or elements of the Quality Management System (QMS), including but not limited to Corrective and Preventive Action (CAPA), Internal Audits, Document Control, Training and Qualification, and Metrics and Data Analysis, and various other elements for the site / Business unit. He / She monitors and maintains applicable procedures for that element of the QMS, and develops, implements, or manages applicable instructions, as necessary or directed.
• The Quality Systems Specialist System provides guidance and training to associates for processes associated with their responsible QMS element, facilitates meetings and escalation, and supports departmental and organizational goals and processes.

Essential / Key Job Responsibilities (including Supervisory And/or Fiscal)

• Participates in meetings and escalations.
• Completes applicable job-specific training.
• Demonstrate expert QMS skills and knowledge.
• Other duties and projects, as assigned.
• Participates in regulatory compliance audits and inspections.
• Maintain quality and regulatory expertise for their designated QMS element.
• Assist in developing integrated implementation strategies for a variety of QMS elements.
• Works within the designated QMS element in accordance with process and procedural requirements.
• Ability to benchmark industry trends for a given QMS element and apply results.
• Participates in investigations.

Required Qualifications

• Attention to detail.
• Advanced language proficiency in reading, writing, understanding, and communicating in English.
• Intermediate to advanced computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint).
• Intermediate to advanced organizational and administrative skills.
• Basic understanding of regulations.

Preferred Qualifications

• Basic working knowledge of the regulations.

Education And/or Experience

• Bachelor’s Degree in a related area / technical field or comparable years of experience.
• 2+ years relevant experience.