Primary responsibility for managing assigned supplier(s) relationship and Quality program deliverables. Provides oversight, evaluation, and corrective action of assigned production and supplier quality related issues, including for external processes and suppliers. Generates 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, interpretation and application of statistical methods to various Production/Quality related processes and communicate those through reports, memos, files and presentations. Responsible person for Quality Tracking System (Trackwise) records such as investigations, CAPA, change management and action items. Assist with and serve as the backup for the Quality Engineer assigned to qualification/challenge kit program.ROLE RESPONSIBILITIES:
•Primary Quality contact for assigned suppliers within an assigned commodity class.•Reviews and approves supplier change notifications, issues/investigations and corrective actions.•Ensures component and tooling qualification activities are completed and meet SOP requirements.•Issues supplier corrective action request (SCAR) and reviews/approves SCAR responses per SOP.•Responsible person for records within the Meridian Medical Technologies (MMT) Quality System; ensure timely completion and appropriate documentation of work completed in support of the record closure.•Coordinates activities cross functionally (QA, Operations and Product Technology) to ensure appropriate prioritization of deliverables, both by the QE as well as by the supplier.•Ensure compliance with company procedures, quality standards and government regulatory requirements.•Responsible for review, redline and changes for assigned supplier quality plan (SQP), QC Test Report (QCTR) and controlled drawings.•Participates on teams and provides guidance and direction from a Quality/compliance perspective.•Serves as the backup for QE assigned to the Qualification and Challenge kits program; review defects and confirm answer key to defect, confirm the defect kit against MTR, confirm lack of additional defects; review remaining parts for lack of damage.BASIC QUALIFICATIONS:
Bachelor’s degree in a scientific/engineering discipline required.•3-5 years of cGMP, FDA regulated industry experience; prefer experience within the medical device or Quality Engineering settings. 1-3 years of experience with a Master’s degree acceptable.•Knowledge of computerized systems (MS Office suite).•Demonstrated ability to manage multiple priorities•Professional certification is desirable but not required (i.e. CQA –Certified Quality Auditor, CQE –Certified Quality Engineer, SQE –Software Quality Engineer, etc.)PHYSICAL/MENTAL REQUIREMENTS
Sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Standard work schedule with possible 10% travel
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: November 15, 2021
Eligible for Employee Referral Program
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 Act
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.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 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