POSITION SUMMARY: 

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.

Essential Functions (ACCOUNTABILITIES/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

Qualifications:

Experience

• Five (5) year minimum work experience in a manufacturing environment

Education

• Associate Degree of Quality Assurance (or Technical Field) or equivalent work experience in a Quality Assurance/Control position.

General Skills/Competencies/Specialized Knowledge

• 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

Not Required but Preferred:

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

TRAVEL REQUIREMENTS/WORK ENVIRONMENT and PHYSICAL DEMANDS:

Travel

• Must be able to travel up to 10% of the time.

Work Environment and Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.     Specific vision abilities required by this job include Close vision.