Pfizer Quality Manager, Design Control in United States
Provides quality oversight for design control lifecycle activities for the auto injector platforms. Provides Quality input and review for combination product related design projects, quality system records and design control procedural deliverable requirements. Leads and facilitates risk assessment activities and guides design verification and validation plans. Assesses and improves systems, procedures and practices. Approves protocols and reports as needed. Responsible for oversight of Design Control Lifecycle
Provide oversight to the Product Technology team and manufacturing site to ensure compliance with FDA's regulations / guidance documents as well as site SOPs
Review/Approve impact assessments for complex/significant CAPA and Change Management records and develop execution plans
Facilitate risk assessment activities, risk mitigation strategies and risk management plans; provide review/approval as needed
Review and Approve Design History and Risk File documentation
Utilize Design History and Risk File documents to assess risk resulting from complex/significant changes, manufacturing events and customer complaints
Perform periodic reviews of Design History and Risk File documents to ensure the files remain reflective of data/trending signals and ongoing activities
Provide direction and approval for engineering and development documentation
Provide guidance and approval for protocols and reports ensuring adherence to design control procedures and policies
Provide guidance and oversight for design verification and validation activities.
Lead investigations of device failures to determine root cause and work with teams to implement appropriate corrective and preventative actions
Provide oversight of new drug delivery system projects to R&D and other technical teams
Create test fixtures or components
Review/Approve Combination Product technical assessments
Represent the Quality Unit during Design Reviews
Provide Design Control lifecycle, procedure and policy training as necessary.
Identify and correct deficiencies in procedures and practices
Bachelor's Degree in Engineering or Science
7-10 Years Experience in medical device or combination product manufacturing within the Quality function
At minimum 5 years providing direct oversight to the design control lifecycle and DHF
Well versed in ISO13485 and 21CFR820 requirements
Critical thinking ability and attention to detail
Effective technical writing ability and verbal communication skills
Computer skills including MS Office and MiniTab
Demonstrated applied knowledge of Failure Modes Effect Analysis (FMEA), CAPA, Root Cause Analysis and statistical methods as applied to Quality.
Certified Quality Engineer or Six Sigma Black Belt
Experience with DHF remediation
Able to sit and stand for extended periods of time
Critical thinking and ability to pay attention to detail
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; use hands to finger, handle or feel; reach with hands and arms; climb or balance; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May require work beyond typical business hours
May require travel 0-10%
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.
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.
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.
Other Job Details:
Last Date to Apply for Job: August 30, 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.