Specialist, QA

ICU Medical•Salt Lake City, UT

2d•Onsite

About The Position

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. Essential Duties & Responsibilities Perform quality administration and coordination activities including, but not limited to the following domains: Quality Systems Coordination 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 stake holders, 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 Data & Compliance: 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, 21CFR820 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.) Project Management 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 Safety & Others 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

Requirements

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.

Nice To Haves

Ability to understand and implement cGMP, or ISO 13485 Quality Management System Requirements is preferred

Responsibilities

Quality Systems Coordination
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 stake holders, 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, 21CFR820 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