Essential Duties and Responsibilities:
- Develops and establishes quality systems and procedures to ensure that the quality system is compliant with regulatory and customer requirements.
- Develop, execute and summarize validation and qualification protocols and associated reports. Interfaces with the customer on completion of these items.
- Develop applicable quality inspection specifications and methods.
- Develops and establishes quality systems and procedures, control plans, FMEAs, gage R&Rs, and inspection plans for proposals. Ensures that project and/or process control documentation is compliant with requirements and/or contract.
- Identifies quality performance, trends and corrective action by coordinating with customers and suppliers. Ensures compliance to specified quality requirements by performing in-house and supplier audits and surveys. Develops and initiates programs to improve supplier performance.
- Manages and participates in non-conformance investigation, root cause determination, and corrective actions.
- Refines and enhances products and processes by applying continuous improvement and key lean manufacturing/production principles and techniques to critical areas of production.
- Represents the company by interfacing with customers as well as assisting with internal and external audits. Will act as main contact in audit. Develops and coordinates corrective action procedures and plans resulting from these audits.
- Makes quality-related customer and vendor visits and contacts as required.
- Perform other duties as assigned
Education, Training, Skills and Experience Requirements:
- BS in Engineering or Science discipline preferred
- Competencies to include: analytical, team interaction and communication skills.
- Understanding and ability to use quality tools and manufacturing statistics.
- Minimum 5 years experience in managing quality systems.
- Extensive knowledge of ISO 13485, ISO 9001, and FDA QSR.
- 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. While performing the duties of this job, the employee is regularly required to stand; walk, and sit for extended periods of time.
This position will require you to submit to and pass a drug test and/or background check.
EirMed, LLC will comply with all applicable federal and state laws governing the use of such background checks and drug tests.