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. 

Why Patients Need You

Everything 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.

ROLE SUMMARY

Responsible for implementation of Kalamazoo site Quality Systems for Medical Device/Combination Products. Supports the creation, development and monitoring of Quality and Regulatory Compliance strategies for medical devices and combination products. Ensures inspection readiness and compliance with all applicable medical device and combination product regulations within the scope of the manufacturing site’s activities. This role is integral to continual improvement of processes, supports quality systems improvement efforts, and ensures timely escalation of issues.

How You Will Achieve It

ROLE RESPONSIBILITIES

• Operational Support for the maintenance of Medical Device and Combination Products Quality Management Systems including remediation and continual improvement.
• Development, implementation and monitoring of Quality and Regulatory Compliance strategies for medical devices and combination products.
• Supports inspection readiness and ensures compliance with all applicable medical device and combination product regulations within the scope of the manufacturing site’s activities.
• Provides SME support during Regulatory/Customer audits for products and Medical Devices including contributions to strategies to successfully respond to auditor concerns.
• Supports the evaluation of adequacy and compliance of the site Quality Management System against all applicable medical device/combination product regulations, company policies, and procedures.
• Contributes to quality systems improvement plans.
• Supports training efforts to ensure medical device and combination product quality concepts and processes are understood throughout the site.
• Provides device management representative in preparation for device Management Review Meetings with timely inputs as required for leadership escalation.
• Provides support for MDCP Internal & External Audits and regulatory inspections, participates in internal GMP audits.
• Authors, reviews and / or approves GMP related SOPs and documents. 
• Monitors ongoing industry quality and regulatory compliance matters applicable to device/combination products and ensures required updates are implemented in a timely manner.
• Support technical execution of Design History File (DHF) enhancements / updates.
• Maintains knowledge of product and medical device filings to support inquiry responses from internal and external customers.
• Provides product knowledge and support for regulatory deficiency responses, regulatory annual reports, and the development of other regulatory submission packages.
• Performs data analysis for post market surveillance activities and for internal reports used to inform decisions and actions to drive improvement in regulatory compliance and customer satisfaction.
• Ensures device risk management files are updated regularly incorporating post-production information.
• Develops and monitors key metrics and provides input to device management reviews.
• Reviews and approves change requests for potential impact to device design and/or DHF document impact.
• Supports medical device or combination product issue investigations and assigned CAPAs.
• Reviews PQS requirements related to Medical Device and Combination products and assesses impact to Quality Management System.
• Effectively communicates complex technical issues to all levels of Management, including outside of Quality.
• Maintains positive working relationships with operations, engineering and above site groups. 

Qualifications

Must-Have

BASIC QUALIFICATIONS

• 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
• St