Quality Engineer 3 QCD Lab
The Quality Control Device Quality Engineer (QCD QE) will be primarily based in the Westport STL QC Device Laboratory and provide support with Equipment Qualification, Method Validations, investigation write up, root cause analysis, and project support being managed and supported by the QCD Lab. The ideal candidate will possess a working knowledge of statistical methodology as it relates to Laboratory testing and related production processes.
- Designs and 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 for the QC Device Lab.
- Capable of designing and executing FAT/SAT and Equipment Qualification and Validation on new and assure existing equipment meets compliance.
- Responsible for assisting in creating all applicable process documentation to guarantee laboratory testing processing is 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 for the QC Device Lab.
- Evaluates equipment or process problems and designs testing to determine possible causes or solutions. 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 for test methods and equipment being developed.
- May interact 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/testing issues in the QC Device Lab (supporting investigation write up/approvals as required).
- Assist QC Device lab management 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.
Bachelor’s Degree in an Engineering related field, with eight to ten years pharmaceutical, laboratory, manufacturing or Quality Engineering related experience in medical devices is preferred.
- Certified Quality Engineer, Six Sigma training and Lean Manufacturing training desired but not mandatory.
- Thorough knowledge of cGMPs and internal SOPs related to device testing and 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 Control labs, knowledge of various types of mechanical testing.
- 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.
Position requires the ability to sit and/or stand for extended periods and to work in a variety of settings including office areas, laboratory areas, warehouse, etc. and some occasional time spent in the packaging line. Additionally, the ability to drive between the local St. Louis sites is necessary.
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
Training presentations may be required to be delivered on all three shifts, although the primary shift for this role is 1st Shift.
Observe safety policies and procedures. Practices and promotes safe working environment at all times.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis. This QE’s work will be accomplished while sitting, walking and standing and will require entry into all laboratory areas in Westport. Attendance and participation in various departmental team meetings will also be required. Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.
This position will require travel between the sites multiple locations (approximately 10 miles apart) and occasional travel outside of St. Louis.
Makes decisions of moderate complexity, sometimes with incomplete information and under tight deadlines and pressure. Makes sound decisions based upon a mixture of analysis, wisdom, experience, and judgment. Always acts with integrity.
Deals with concepts and complexity comfortably – intellectually sharp, capable and agile. Understands when to inform, consult or escalate. Summarizes information succinctly and accurately and provides clear recommendations based on a combination of the information at hand and regulatory/procedural guidance. Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (“green card holders”), Refugees and Asylees.
Last date to apply for job: October 1, 2021
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer 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.EEO & Employment EligibilityPfizer 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 as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Quality Assurance and Control