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NESCO Resource is currently recruiting for a Quality Assurance Engineer for a contract position with our client located in South Tucson, Arizona.
The Quality Assurance will support various Quality System activities such as internal audit, CAPA, investigations, procedure updates, and be the quality representative on project teams. The ideal candidate will have a strong knowledge of medical device/in-vitro diagnostic environment. Strong organizational skills and experience in Quality Management Systems administration is required for this position. Good communication and documentation skills are necessary in this highly regulated environment.
Roles and Responsibilities:
ISO 13485:2016 subject matter expert
MDSAP audit preparation – Nov 2018
FDA facility inspection readiness - TBD
Performs internal audits.
Coordinates QMS data analysis and reviews processes for audit readiness.
CAPA and Task Management
Provide support to establish and/or maintain processes to ensure investigation findings prevent recurrence or occurrence issue
Maintain status and compliance to due date,
Confirms implementation of Tasks and CAPA actions.
Provides support to owners to ensure timely completion of investigations and thoroughness of documentation.
Evaluates the completeness of investigations and close investigations.
Perform and maintain advanced analyses of QMS metrics. Trend, analyze, and report on the status of quality systems including measurement of trends.
Communicate data and information on a regular basis; provide information to the management review process.
Project Core Team Member
Represent the Quality Assurance function at Core Team meetings, providing input to the project with respect to compliance to procedures and applicable regulations.
Review and approve protocols and reports, ensuring compliance to procedures and applicable regulations.
Participate in FMEA creation and revisions, and other risk management activities.
Bachelor's Degree in Science, Engineering, or related experience and 5 years related experience in medical device industry, preferably in in-vitro diagnostics.
Advanced knowledge of Quality Assurance in a medical device/in vitro diagnostic manufacturing environment, including Design Controls.
Advanced knowledge of FDA QSRs, IVDR, CMDR, ISO 13485, ISO 14971 and other applicable standards and regulations.
Strong experience with MS Office.
Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.
Willingness to be flexible and adaptable to changing priorities.
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.
Strong 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.
Creates and maintains strong, positive working relationships.
Effectively communicates, written and verbal, at all levels both internally and externally.
For immediate consideration apply now and/or contact me directly: Kristy Ramos at 520-505-4667.
If you would be interested in other positions in Tucson, we have several additional opportunities available please see www.nescoresource.com for more openings. If you know someone looking for a new opportunity we will pay you for your referrals!
NESCO Resource was named Best of Staffing for both client and staffing 6 years in a row! We offer medical, dental, vision, short term disability, life insurance and 401K!! We are excited to work for you!
At NESCO Resource, our flexible staffing solutions include contract, contract-to-hire, and direct placement services. We employ specialized recruiters focused in the fields of Engineering, Information Technology, Accounting & Finance, Administrative & Customer Service, and Manufacturing & Distribution.
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