QA Engineer I – Diagnostic

Medline Industries, Inc. has an immediate opening for a QA Engineer 1 for the Diagnostics Division , based in Northfield, IL headquarters.

Will Assist with routine inspections and set basic quality standards for both in-process and finished products and materials. Develop methods for testing, sampling and training. Evaluate production and recommend improvements. Qualify and conduct vendor management. Products will include and not limited to blood pressure monitors, thermometers, sphygmomanometer and various lab products manufactured and distributed by Medline. Will also include fluid delivery products such as Syringes, Needles, I.V. Sets and Sharps Containers. We are seeking a dynamic, hardworking professional with a solid education and background in quality along with a desire to work for a fast-paced, large corporate organization. In addition to exceptional leadership potential and analytical skills, you must have a “roll-up your sleeves” attitude.

Responsibilities include:
* Assist Quality staff with inspections and review of production processes.

* Develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Design experiments to understand sources of variation affecting products and processes.

* Design and install testing equipment and perform product testing and analysis to maintain quality levels and minimize defects and failure rates.

* Analyze reports and defective products to determine trends and recommend corrective actions. Use concepts of probability and statistical quality control to guide decisions.

* Collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented and contribute to supplier quality improvement programs. Participate/lead in supplier qualifications.

* Work with quality inspection supervisors to train and oversee inspectors in their use of control forms, procedures and correcting quality problems.

* Participate as the Quality Representative in Product Development and Design Control activities.

* Participate in Risk Analysis and CAPA processes.

* Coordinate lab testing as required.

* First article evaluation per approved test and product evaluation SOP. Coordinate or perform inspections of new products or products from new vendors.

* Ensure compliance with applicable domestic and international regulatory requirements associated with product lines and processes.

Education
* Bachelor’s degree in Engineering – related fields.

Relevant Work Experience
* At least 1 year of relevant experience in the Quality or Engineering field..

Preferred Qualifications

Education
* Master’s degree in Engineering or related field.

QA Supervisor

Job Description:

Quality Assurance Supervisor, Cleveland, MS – 2nd Shift

The Quality Supervisor will lead a staff of Quality Associates and Technicians that perform daily quality assurance activities and functions in all classified areas. The Quality Supervisor will ensure that staff performs routine tasks in a timely manner according to established Standard Operating Procedures through direct observation and review.

RESPONSIBILITIES:

* The Quality Supervisor will assist the Quality Manager in assuring core values are continually emphasized and kept in the forefront of facility operations.
* Will be responsible for all Quality Assurance aspects of all classified areas in the Facility. This will include coordination with Facilities Maintenance on all certification / recertification, maintenance / preventative maintenance (PM), Monitoring, and audits of the sanitization process. Will investigate any non-conformances and out of compliance issues related to these areas. Will review all documentation related to the classified areas.
* Will be responsible for all Quality Assurance aspects related to aseptic processing. Will ensure routine daily audit of processes to ensure compliance to policies and procedures. Will coordinate the investigations, corrective actions and preventative actions of all non-conformances. Ensure the disposition of potential nonconforming product is disposition in an efficient and timely manner.
* Will coordinate with Pharmacist in Charge to ensure all Pharmacy Technicians are compliant and up to date with all training, certifications and qualifications required. Will ensure all documentation is current.
* Ensures compliance to procedures, governing regulations and address non-compliance issues.
* The Quality Supervisor will set the tone for quality processes and services to deliver safe compounded preparations to hospital customers.
* Will conduct internal audits of processes, systems and procedures.
* Participate in cross-functional teams to identify effective corrective and preventive actions to improve Lean process quality.
* Working with Quality Manger will assure timely closure of audit items.
* Will initiate SOP revisions as needed to assure compliance, continuous improvement of overall operation.
* Ensure all Quality related documents generated at the Facility are received into the Documentation Center at the appropriate time per procedure.
* Other duties and responsibilities as assigned.

Qualifications

* Bachelors Degree in Science or related field required.
* Aseptic processing experience desired not required
* A must: Minimum of 2 years experience in Quality, or related field in the healthcare or pharmaceutical or medical device industry. (Cosmetics and food are acceptable industries)
* Team lead or supervisory experience required.
* Demonstrated understanding of quality assurance in a regulated (FDA, DEA, ISO) environment a plus
* Thorough understanding of the Governmental requirements in a sterile processing environment.
* Computer skills in word processing, spreadsheets and databases required.
* Effective problem solving, supervisory, strong communication (written and verbal) and organizational skills