Manager Medical Device & Combination Products Quality Assurance

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.

What You Will Achieve

Complaints QA Manager 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.

This is an onsite position that will be located in San Jose or Emeryville, CA.

How You Will Achieve It

Responsibilities 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 procedures
Partner 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 colleagues
Responsible for communication and escalation of MDCP quality issues within Pfizer
QA oversight of facility, utilities, equipment, computer system validations and change controls
Support Management Review & Quality Councils as required
Perform internal audits against 21 CFR 820, ISO 13485 and ISO 14791
Responsible 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 standards
Responsible for maintenance of the PGS Vendor management quality system for assigned vendors
Responsible for communication and escalation of vendor-related quality issues within Pfizer:
Maintain close working relationship with Pharmaceutical Sciences, Legal Manufacturers and other QA lines.
Lead and support investigations of significant quality and/or regulatory events associated with external suppliers

Qualifications

The successful candidate will have the following:

Skills:

Other Job Details:

Relocation assistance may be available based on business needs and/or eligibility.