Quality Operations Sr. Associate, Medical Device & Combination Products

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. 

What You Will Achieve

In this role, you will:

This role is part of Pfizer’s Medical Device and Combination Products (MDCP) Quality Operations. The Quality Assurance Senior Associate supports product development and sustaining engineering teams by reviewing Design History Files (DHFs) for compliance with CFR 820.30, ISO 14971, and other regulations affecting device and drug-device interfaces. The Senior Associate collaborates across functions to ensure products meet safety and regulatory standards.  Your specialized knowledge will contribute to achieving team goals within Pfizer’s quality system, necessitating exceptional communication, analytical, and consensus-building abilities. This role requires a self-motivated professional who can proactively identify and address issues, communicate across all organizational levels, prioritize quality, assist in completing critical deliverables, clarify complex matters, and foster effective teamwork.  

 

In this role you will:

• Act as the quality assurance and medical device quality lead supporting MDCPs through reviews and approvals of all MDCP lifecycle documentation including design controls, risk management, quality management systems, change controls, vendor management, and complaints.

• Ensure device design, development, commercialization, complaint, and manufacturing documentation of medical devices and MDCPs meet appropriate regulatory requirements by providing guidance through all stages of life cycle management in accordance with 21 CFR 820, ISO 13485, IEC 62366, IEC 62304, ISO

• Identifies, leads development of, and participates in implementation of new processes/programs for quality improvement. 

• Provide support for audits and inspections by FDA, notified bodies, competent authorities, and other third parties.

• Provide guidance, recommendations, and support in the authoring of implementation plans for adherence to new regulations, standards, and procedures.

• Well versed in quality investigation techniques.  Assist in investigating deviations related to laboratory, design verification, validation, or manufacturing activities.

• Reviews and approves project related documentation including protocols, validations, complaint/non-conformance records, supplier assessments, and quality agreements.

• Interact with functional departments, suppliers, and experts to implement quality goals.

• Apply ISO and QSR requirements to processes and procedures internally and externally.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience;
  OR an associate's degree with 6 years of experience; OR a high school
  diploma (or equivalent) and 8 years of relevant experience

• Technical knowledge related to either pharmaceutical manufacturing/development and/or the design/operation of medical device or drug combination product platforms, design controls, risk management, 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.

• Knowledge and application of device root cause analysis methodology and device CAPA requirements

• Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues

• Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement

Bonus Points If You Have (Preferred Requirements)

• The combination of pharmaceutical and / or medical device development experience preferred

• Understanding and application of cGMP specifically 21 CFR 820, Rule 21 CFR “4” current good manufacturing requirements for Combination Products and the principles and concepts of relevant quality processes and systems

• Experience in risk management and design control of medical devices, combination products from c