Quality Engineer, medical device
Proclinical is currently recruiting for a Quality Engineer of Medical Device with a pharmaceutical company located in St Louis, MO. Successful candidate will assist in the oversight, evaluation, and corrective action of all production and supplier quality related issues, including outside processes and suppliers with an emphasis on medical devices and Combination Products.
- Designs, executes Quality Engineering related protocols; and summarizes studies to ensure consistency of data production and compliance with manufacturer and specifications with current Good Manufacturing Practices.
- Capable of designing and executing MSA on new and existing equipment.
- Responsible for quality and process related issues for outside suppliers.
- Responsible for assisting in creating all applicable process documentation to guarantee production processing consistent within validated parameters.
- Capable of singular project management (within the realm of Quality Engineering) management/direction for smaller scope Quality Engineering Plans.
- Issues data, memos, presentations and reports concerning Quality Engineering projects or areas of interest.
- Evaluates equipment or process problems (internal and at suppliers as needed) and designs testing to determine possible causes or solutions; assists in determining process capability of new equipment. May also be called on to harmonize measurement techniques between the site and supplier.
- Assists in ensuring product development activities have all necessary Quality Engineering supporting justifications.
- Interacts with third party customers, outside testing laboratories and provides Quality Engineering assistance where needed on specific issues.
- Assists in identifying root causes and coordinate corrective action to quality issues in Packaging and Inspection and the Sterile Facility.
- Quarantine product or components as necessary.
- Training inspectors, SQC technicians, and supervisors on the following: new procedures, new equipment, new measurement methods, new inspection criteria, Component/product defects and failure modes.
Skills and Requirements:
- Bachelor's Degree in an Engineering related field, with four to ten years pharmaceutical, laboratory, manufacturing or Quality Engineering related experience in injection molding preferred.
- Certified Quality Engineer, Six Sigma training and Lean Manufacturing training desired but not mandatory.
- Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective action/Preventative Action (CA/PA) for recommendation to management.
- Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of other departments.
- Math Ability: Ability to understand and apply towards Quality Engineering tasks, mathematical concepts especially as it relates to statistics and probability. Ability to apply mathematical operations to such tasks as frequency distribution, determination of tests, analysis, sampling, and process capabilities.
- Great sense of humor and candor and persistent to move project work forward - capable of diving in, sometimes working out of role, and pushing rope
- Excellent self-management, time management, and problem-solving skills - predict problems and find solutions
- Ability to be flexible, resilient, and adaptable to changing priorities in a fast paced, high pressure environment.
- Exercise sound judgment and ability to work effectively with a diverse workforce.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Max Kelly at (+1) 312-270-1613 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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