Pfizer Inc. Hiring for Manager Medical Device & Combination Products Quality Assurance at Fairmont, West Virginia Full Time

Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will AchieveMedical Device and Combination Products Quality Assurance is part of the PGS organization and provides quality support to Pharmaceutical Sciences and Global Technical Engineering (GTE) for the lifecycle management sustaining, product development & commercialization of Medical Devices and Combination Products.This role has responsibility for the oversight, support and delivery of the Medical Device and Combination Products (MDCP) development portfolio in partnership with Global Technical Engineering (GTE).How You Will Achieve ItResponsibilities include but not limited to:Act as the medical device quality support for the lifecycle management projects (GTE) and ensuring QMS execution and continuous improvement.Ensures policies and procedures for assuring that the quality assurance and compliance requirements of the company are being followed during lifecycle management execution.Provide Quality Assurance for sustaining/maintaining the MDCP projects by Global Technical Engineering, Peapack US.Provide Quality Assurance support and direction to GTE project teams assigned to for MDCP projects, complaint investigations and/or design change management.Ensure device design and development meets appropriate regulatory requirements by providing pro-active guidance through all stages of development in accordance with 21 CFR 820, ISO 13485, IEC 62366, IEC62304 and MDCP proceduresPartner with PGS /GTE device personnel and project teams, as required, in the resolution of Medical Device Corrective Action and Preventive Action (CAPA) and complaints.Ensure risk management activities are developed in accordance with ISO 14971 and MDCP procedures.Provide device design and development quality expertise to Pfizer Global Supply (PGS) sites and device contractors as required.Provide device expertise to PGS audits of external contractors involved in device development and manufacture.Provide technical mentorship to colleaguesResponsible for communication and escalation of MDCP quality issues within PfizerQA oversight of facility, utilities, equipment, computer system validations and change controlsSupport Management Review & Quality Councils as requiredPerform internal audits against 21 CFR 820, ISO 13485 and ISO 14791Responsible for working with business lines and managing all Quality and compliance aspects of external contractor activities & oversee GMP work placed with the contractor related to medical device/combination products to ensure consistency and compliance with regulatory expectations and company standardsResponsible for maintenance of the PGS Vendor management quality system for assigned vendorsResponsible for communication and escalation of vendor-related quality issues within Pfizer:Maintain… For full info follow application link.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.