Amsino Medical, Inc is dedicated to providing the highest quality medical products and services at the most competitive prices, creating the best value for our customers worldwide. We believe that complete customer satisfaction in all areas of our operations - product design and development, engineering and technical support, manufacturing, quality control and inspection, shipping and logistics, sales, marketing and customer service - is the key to our success and future growth. Underlying this mission is the recognition that our employees are vital in achieving the company's goals and enhancing our reputation as a world class manufacturer and an innovative leader of high quality and cost-effective medical products.
Director of Quality
As the Director of Quality, you will be responsible for managing the efforts and functions of Quality Assurance staff at Amsino Medical, Inc and Amsino Healthcare (USA), Inc. You will manage the inspection staff and processes for all products manufactured by or for Amsino. We will rely on you to provide liaison expertise with regards to system failures and troubleshooting. You will also perform the functions of the Management Representative.
The scope of the Director of Quality will include the approval for use of all incoming/in-process materials and finished goods, rejection of any materials that are found not to meet specifications, and approval or rejection of all controlled documentation used within the facility. The impact of errors made from this position can be very serious, including health related issues for the end users of the products manufactured, regulatory status of the facility, and company reputation.
- Direct Vernon Hills and Aurora operation to be compliant with current Good Manufacturing Practices for Finished Pharmaceuticals, Medical Devices, and ISO-13485 standards.
- Implement and certify Amsino Medical, Inc. ISO-13485 system.
- Host FDA, ISO and Customer audits.
- Manage site quality functions to be audit ready at all the time.
- Manage internal audits.
- Complaint handling and CAPA.
- Interface directly with and provide knowledge and expertise to upper management on aseptic filling and pharmaceutical cGMP compliance issues.
- Develop Quality Assurance staff to meet all site needs.
- Provide technical liaison and management support for the manufacturing, testing, and regulatory filings for existing and new products.
- Manage the Quality Assurance staff for the sampling and inspection of all incoming and in-process materials. Ensure that the inspection processes are properly maintained and in compliance with company SOPs and cGMPs. Review and approve the inspection summaries for completeness, legibility, and accuracy - to include all incoming and in-process materials.
- Ensure that Validation processes are properly maintained and in compliance with company SOPs and cGMPs. Write protocols for installation, operational, and performance/process qualification studies. Implement requirements of protocol, assemble data, perform data reduction, and write a summary of the results. Assemble the protocol, data, and summary into a validation package to be approved within the organization.
- Ensure the product Stability Program is managed according to established procedures, protocols, and schedules. Ensure that all aberrant or non-compliant test results are reported, handled, and dispositioned properly.
- Perform investigations into product or process failures and non-conformances. Identify and resolve product quality issues.
- Perform batch record review and release for all finished products.
- Ensure facility Calibration Program is managed according to established schedules. Ensure that all non-compliant instruments are properly identified and removed from service.
- Ensure the quality system requirements are effectively established and maintained. Report on the performance of the quality system to management with executive responsibility for review.
- Perform and document the on-the-job training of QA staff for all existing, new, and revised test methodology. Maintain departmental training records.
- Assist in the development and implementation of new processes and/or equipment. Upon completion, perform training of personnel in the respective departments.
- Interface with regulatory agencies during on-site inspections.
- Perform performance/salary review of Quality Assurance staff. Handle routine personnel administration issues, as necessary.
- Perform and provide periodic departmental activity and status reports or other duties.
- Additional duties may be assigned.
- Bachelor's Degree in a scientific discipline.
- Minimum 10 years' work experience in a pharmaceutical or health care related facility.
- Previous management experience in a health care manufacturing environment.
- Previous experience with statistical process controls.
- Proven track record of hosting successful audits like FDA.
- Exceptional written and verbal communication.
- Clear, concise, and courteous inter-personal communications skills.
- Proven track record of leading people and organizations toward pre-defined goals.
- Able to cross between technical tasks to managerial tasks seamlessly.
- Make plans for all current and future product needs with regards to quality related issues.
- Make judgment decisions on actions that may impact product quality.
We value our employees' time and efforts. Our commitment to your success is enhanced by our competitive pay and an extensive benefits package including paid time off, medical, dental and vision benefits. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow within the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.