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Quality Systems Spec


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Job Title:Quality Systems Spec
Job ID:16186
Location:Columbia Heights MN 55421
Duration:12 months

Please note: Actual auditing experience preferred.

Position Description:
Perform a variety of quality duties supporting audit readiness in the Quality System area of Production and Process Controls. This position will support audit readiness activities and/or support day to day responsibilities.

Position Responsibilities:
Work directly with operation personnel to ensure compliance to specifications and requirements.
Perform audit readiness activities by evaluating documentation, records and ensuring personnel are audit ready.
Document applicable data on quality and manufacturing forms and processes.
Identify, lead or manage quality system improvements. Improvements to focus on effectiveness, efficiency and when applicable drive simplification.
Provide support to the department and site as needed during audits and inspections.
Provide oversight support on the completion of CAPA and nonconformance activities.
Perform other related Mfg quality duties as required or assigned by the supervisor.
Attend meetings as required by manager.
Work with minimal supervision.

Basic Qualifications
1-4 years of experience with a Bachelors degree OR
0-2 years of experience with a Masters degree
Experience working in a team environment.
Effective verbal and written communication, analytical, influencing and interpersonal skills.
Must be able to communicate at all levels and across company lines.
PC skills, word processing, spreadsheets, project management, etc. Basic Statistical Knowledge and Application
Adhere to the Client Core Behaviors of Customer Focus, Candor, Trust and Respect, Courage, Accountability, and Passion to Win

Education Required:
Bachelors degree in science or engineering

Desired/Preferred Qualifications (Optional):
Previous medical device or other regulated industry experience
Experience in or support of manufacturing operations.
Change control documentation systems (e.g. Agile, Enovia or Documentum)
CAPA documentation systems experience (e.g. Trackwise)
Knowledge of all aspects of medical device operations (quality, manufacturing, supply change, design).
ASQ certification as CQM, CQE, CQA
Experience revising and improving an existing quality management system
Working knowledge of Quality System Regulation (21CFR820), ISO 13485:2003.
Solid judgment and problem solving skills
Ability to manage multiple projects or priorities
Strong influence and negotiation skills

Contact Person: Manju

If you are interested in this job then you can reach me at 2015249600 X 7944.

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