QA Inspector

Argentum Medical•Geneva, IL

About The Position

The IQA Inspector role supports manufacturing quality assurance activities of Argentum Medical. This position tests and inspects products at various stages of production process and maintain quality and reliability of products.

Requirements

Five (5) year minimum work experience in a manufacturing environment
Associate Degree of Quality Assurance (or Technical Field) or equivalent work experience in a Quality Assurance/Control position.
Communication – Communicates effectively at all levels of the organization. Expresses ideas clearly and simply both verbally and in writing. Promotes timely, ongoing flow of information to others. Communicates and listens effectively in order to develop and maintain key business relationships.
Interpersonal Skills – Ability to work with co-workers and customers, both internal and external, of all levels. Ability to professionally interact and build constructive and effective relationships with all levels and functions within the company. Ability to effectively interface with others on behalf of the organization.
Presentation Skills – Demonstrated ability to present 1:1 or in group settings. Delivers a clear and compelling message tailored to the needs of the audience.
Initiative – Ability to work well independently and exercise appropriate judgement under general direction. Ability to prioritize workload, goals and tasks consistent with the department and corporate objectives. Ability to multi-task, complete concurrent projects within given time frames and manage interruptions and change requests.
Problem Solving – Uses logic to solve problems. Proves all sources for answers. Looks beyond the obvious. Applies appropriate theory and principles, expert judgment and cross-functional expertise to address problems.
Decision Making – Makes timely, sound decisions based on analysis wisdom, experience and judgement. Utilizes a high degree of creativity and latitude. Relies on experience and good judgement to ensure that expectations are met and that business objectives are achieved.
Adaptability – Embraces and adapts to change and demonstrates a willingness to learn. Reactionary and adaptable to abrupt changes, arising issues, extreme time pressures and other exigent circumstances. Ability to respond quickly to change, and to prioritize actions to meet customer needs.
Trust and Integrity – Interacts with others in a way that gives them confidence in one’s intentions and those of the organization. Accepts responsibility for one’s own decisions and actions. Demonstrates honesty. Keeps commitments. Behaves in a consistent manner and is open, honest and trustworthy.
Collaboration and Teamwork – Works collaboratively and cooperatively with many teams cross-functionally. Ability to work well with other people to solve problems and to find the best solution. Energetic and willingness to work closely with all team members to achieve success.
Customer Orientation – Demonstrates a keen understanding of various customers’ (internal or external) needs and utilizes a variety of internal resources to provide solutions and a compelling value proposition.
Project Management – Ability to plan, organize and manage resources to bring about the successful completion of specific project goals and objectives. Works well within a metrics-driven environment.
Analytical Skills – Strong analytical skills. Proven ability to analyze and interpret data, to provide guidance, data driven decisions and recommendations.
Computer Skills – Proficient computer system-based tools including Microsoft Office applications, presentation, e-mail, web browsers and spreadsheet software. High computer literacy as it relates to database management and engineering software platforms.
Able to read and understand Work Instructions
Conduct inspections using calipers, micrometers, custom gauging, optical comparators, gauge pins, gauge blocks and other technical measuring devices
Working knowledge of geometric dimensioning and tolerance
Proficient with mechanical drawing

Nice To Haves

Working knowledge of ISO 13485 and FDA requirements
Knowledge of Statistical Method
ASQ CQI or CQT Certification

Responsibilities

Perform required inspection and testing of incoming product according to quality control plan
Perform first article inspection and testing for Engineering
Perform in-process and pouch seal inspection according to quality control plan
Perform first article label inspection for finished product
Final inspection on Over label work order
Provide assistance in the overall implementation and administration of Company policies and procedures
Document and maintain accurate records of inspection and calibration results
Communicate with appropriate Quality, Operations and Engineering personnel to ensure product and customer requirements are continually met
Clearly document non-conformities and communicate issues to Quality and engineering personnel
Assist with the Material Review Board process for the disposition of material, parts and finished product
Control non-conforming material, parts and product in accordance with documented procedure
Maintain QA Hold Area up to date
Maintain Incoming Quality Inspection, SCAR, DHR records up to date
Process owner for CAPA and SCAR process -Trending, tracking, ensuring deadline, Monitoring overall program
Coordinate with Supplier for SCAR, Complaint or on open other investigation
Assist with the development of inspection requirements and techniques
Ensure calibration and maintenance is performed on inspection equipment
Read and interpret inspection data from outside sources
Participate in Quality audits to verify compliance with documented procedures and regulatory requirements
Implement process controls by promoting and following all safety and quality system procedures as well as Company policies
Conduct or assist with supplier auditing
Conduct particulate counts in Environmentally Controlled Room in accordance with documented procedure
Any other duties or responsibilities required or assigned by Director or Associate Director of Regulatory Affairs and Quality Assurance