QA Inspector

Hours:

1st Shift Mon-Fri

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.

• 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

• 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 judgement 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…