Specialist, QA

Position Summary

The Quality Assurance Specialist will coordinate and ensure compliance of various elements of the ICU Medical Quality System such as (but not limited to) – CAPAs, NCMRs, SCAR Review Boards, Data Analysis, Management Reviews, Change Orders, Sample Analysis, QA Verification Activities, among others. A successful candidate will have good project management, communication and collaboration skills and be able to work in a dynamic and fast-paced manufacturing environment to support the Operations Quality Engineering team.

This position is 100% onsite at our Salt Lake City, UT manufacturing facility.

Perform quality administration and coordination activities including, but not limited to the following domains:

• Act as an NCMR-B, CAPA and SCARs Coordinator for SLC site
• Collect, analyze and file non-conforming product samples for NCMR-B reviews
• Coordinate bracketing and containment activities of non-conforming materials
• Support quality engineers and management with product investigations, collection and analysis of data, etc.
• Work with various inspection equipment such as gages, calipers, etc. to perform sample analysis
• Collaborate with internal teams such as materials, QA, FQA, Engineering, Validation Lab, etc.
• Perform activities towards creation, disposition and closure of NCMRs.
• Coordinate with internal stakeholders, sister facilities and external vendors/suppliers as per direction from quality engineering and management towards resolution of quality issues.
• Coordinate shipment of non-conforming or build at risk materials between sister facilities.
• May assist FQA with resolution of any compliance issues related to NCMR materials, associated work orders etc.
• Ensure compliance of CAPA system. Performs CAPA coordination activities via weekly/monthly CRB reviews and working with CAPA owners to establish action plans etc.
• Create presentations for CAPA & SCAR Review Boards; run daily NCMR-B, management reviews etc.
• Other professional tasks as assigned by the manager

• Ensure clean data via implementation of quality at source with regards to data accuracy.
• Perform monthly tracking & trending of various quality metrics and deliver to local & global teams.
• Perform automation of data and improve the systems to reduce manual work and redundancies.
• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
• Conduct in-process inspections and internal audits to ensure compliance with regulatory requirements (ISO 13485, 21
  
  CFR
  820 etc.), and internal standard operating procedures.
• Trains QA personnel on GMPs, defects, best practices etc.
• Assist with internal quality system audits.
• Evaluates and addresses deficiencies for potential impact on product compliance status.
• Maintains a controlled documentation system including Quality System data and records.
• Ability to use various software such as Power BI, Microsoft Suite (Excel, Word, Power Point, Project etc.)

• Create action plans, project plans or road maps and provide regular updates to site leadership
• Collaborate and communicate effectively across various levels and geographies of the organization
• Drive compliance and completion of activities in a timely fashion

• Participate in meeting departmental goals and objectives
• Conduct safety inspections and take prompt action to eliminate work hazards
• Performs other professional related duties as assigned or required

• Ability to independently exercise sound judgment for defined job duties, obtain results, troubleshoot problems, and formulate solutions.
• Self-starter, highly motivated, and hands-on.
• High attention to detail and accuracy.
• Ability to manage multiple tasks.
• Proven ability to work effectively alone and in a multi-disciplinary team.
• Works collaboratively with staff at all levels, to advance quality improvement efforts and promoting a culture of quality, continuous improvement, responsibility, and mutual respect.
• Experience with tools such as Power BI, MS Excel, Word, Power Point, Macros, Visual Basic Programming etc. for automation of data analysis.
• Excellent communication and collaboration skills
• Follows regulations, norms and procedures. Promptly responds to customer’s requests / customer focus

• Must be at least 18 years of age
• 2-4 years prior experience in the medical devices or other regulated industries or manufacturing setting
• Four-year degree in science or quality-related fields. Other credentials may be considered.
• Ability to understand and implement cGMP, or ISO 13485 Quality Management System Requirements is preferred

• Some lifting may be required when working with materials related activities
• Must be able to occasionally move and lift objects of up to 30 lbs.
• Typically requires travel less than 5% of the time