QUALITY ENGINEER, MEDICAL DEVICE
Assists 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.
Additionally, assists in generating reports, memos, files, and presentations necessary to communicate the issues for the items listed above according to site procedures. Create, schedule, execute and summarize Quality Engineering related protocols. Assist in the process of gathering, interpret and apply statistical methods to various Production/Quality related processes and communicate those through reports, memos, files and presentations.
Assist in training personnel on unique defects, protocols, measurement techniques and procedures. Able to demonstrate and use as necessary all relevant lab measurement devices.
Knowledgeable with FDA Design Control Regulations and Guidance for Devices or Combination Products (21 CFR Part 4, 21 CFR Part 820) and medical devices.
· Designs, executes Quality Engineering related protocols; and summarizes studies to ensure consistency of data production and compliance with manufacturer and Pfizer 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.
· Assist SQC lab supervisor with technical issues involving injector functionality, component testing, and protocol execution.
· Assists in compiling quality data, which includes: gage R&R studies, process capability studies, trending of product defects, trending of functionality data for finished product, dimensions on components or finished product, raw material inspection/sampling, incoming component inspection.
· 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.
· 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.
· Thorough knowledge of cGMPs and internal SOPs related to Quality Validation. Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ISO standards, ASTM standards, etc.
· Knowledgeable with FDA Design Control Regulations and Guidance for Devices or Combination Products (21 CFR Part 4, 21 CFR Part 820) and medical devices.
· 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.
· Ability to interpret an extensive variety of technical instructions in mathematical or diagram form (component and assembly drawings and GD&T symbols) and deal with several abstract and concrete variables.
· Proficient in Microsoft Office (Word, Excel, Access, PowerPoint), Microsoft Project, Statistical Software (such as; MiniTab, StatGraphics, PH Stat, etc.) and Data Acquisition Software (such as; ASI, Datamyte).
· Experience with medical device plastic molding, manufacture/processing of plastic injection molding, glass molding for cartridges, rubber compounding and molding, metal stamping operations, labels and packaging, printed material manufacture and control, measurement equipment and calibration techniques. Familiar with various measurement gages used in Quality labs, knowledge of various types of mechanical testing.
· 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.