Quality Assurance Specialist

Organization

Accelerate Diagnostics

http://www.axdx.com

Job Location

3950 S Country Club Road

Suite 470

Tucson, AZ 85714

Benefits

Health, Vision, Dental, 401k, ESPP, Relocation, On-site Gym, Weekly Yoga, Friday catered lunches, Employee discounts, 10 paid holidays, On-site car wash, dry cleaning, pet insurance, legal assistance, HSA, FSA, Identity theft, Short/long term dissability, Employee assistance program, Basic and Voluntary LIfe/AD&D insurance, and term Life Insurance

Job Description

Job Title: Quality Assurance Specialist

Location: Tucson, AZ

Position Overview:

The Quality Associate works with Quality Management in reviewing device history records, releasing incoming materials through finish product, working with other functions to resolve quality problems, and other activities that maintain and ensure the continued effectiveness of the Quality Management System. This position will work through all phases of the product life cycle to ensure compliance and business requirements are met and produce products and services that meet the established criteria.

Essential Functions:

- Review incoming inspection records and release materials.

- Review associated DHR and release materials.

- Releases incoming materials and spare parts for use.

- Review related NCRs, associated investigations, and assign necessary corrections and CAPAs.

- Work with groups within the organization to get corrections and clarifications to Device History Records.

- Utilize Agile for Document and QMS record management.

- Utilize QAD for inventory transactions and verification of product information.

- Builds relationships and works well with different departments and all position levels.

- Willingness to support Operations and R&D on quality issues and concerns.

Requirements

Qualifications:

- Bachelor’s degree in related field of study; equivalent work experience in lieu of education may be considered.

- Minimum of 2 years related work experience, preferred; level/quality of education in lieu of work experience may be considered.

Knowledge, Skills and Abilities:

- Introductory knowledge of Quality Assurance in a medical device manufacturing environment.

- Introductory knowledge of Quality System Regulations (21 CFR 820, 803, 806), and guidelines, ISO 13485, ISO 14971, In Vitro Diagnostics Directive (IVDD), and other international regulations such as Medical Device Directive (MDD), SFDA, TGA, and Canadian Medical Device Regulations (CMDR).

- Computer skills with proficiency in Microsoft Office Suite: Word, Excel, Access, Outlook, Internet Explorer.

- Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.

- Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision.

- Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast paced environment.

- Understands interconnections between the supplier manufacturing processes and the use of materials

- Project management skills and experience to complete assigned tasks/projects in a timely and effective manner

- Ability to interpret and apply compliance and quality requirements

- Effectively handles ambiguity and a rapidly changing environment

How to Apply

Accelerate Careers

About Our Organization

Accelerate Diagnostics purpose is to develop revolutionary technology for the microbiology lab.

Technologies and tests that accelerate lab results and drive better clinical outcomes for patients with serious infections.

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