Pfizer Quality Engineer 3 in United States
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 device plastic molding . 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. Able to perform all duties required of a Quality Engineer I not specifically listed in this job description.
Essential Duties and Responsibilities of this position include but are not limited to:
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. 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.
BS in an Engineering related field, with two to four 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. Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective action/Preventative Action (CA/PA) for recommendation to management.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to read, analyze, and interpret 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.
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. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. 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.
To perform this job successfully, an individual should have a working knowledge of 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).
Process and Material Skills:
Familiarity of some of the following processes; primary to job, 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.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment.
This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. §1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. §1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Last Date to Apply for Job: October 1, 2018
Eligible for Relocation Package
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.