Manager, Quality Systems

Manager, Quality Systems

Job Overview

Location
Medina, New York
Job Type
Full Time Job
Job ID
32665
Date Posted
8 months ago
Recruiter
Albert Thomas
Job Views
35

Job Description

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

SUMMARY:

This position is responsible for the Baxter-Medina Quality Management System including the Document Control, Records Management, Training, Change Control, Internal/External Audits, Management Controls Corrective and Preventive Action and resources.

Quality Management System (QMS).  This primary responsibility of this role is the establishment and maintenance of the Baxter-Medina QMS to ensure compliance with all applicable QMS requirements, including 21 CFR Part 820 and related FDA requirements, ISO 13485:2003 and related regulations and standards, other relevant international requirements, as well as Baxter corporate QMS requirements.  This individual works closely with Baxter-Medina’s Management with Executive Responsibility (MWER) and Quality Management Representative (QMR) to ensure that:

  • The appropriate organizational structure, resources, responsibilities and processes, policies, procedures, documents and records have been established and are maintained to meet the QMS requirements;

  • The QMS is suitable for all operations including, manufacture, packaging, labeling, storage, and distribution; and

  • The QMS is effective in maintaining the quality, safety and effectiveness of Baxter-Medina products.

Document Control & Records Management.  This role is responsible to establish and maintain an effective document control system, and to ensure all documents required under the QMS are established and maintained appropriately.  This role is also responsible to establish and maintain an effective records management system, and to ensure all records required under the QMS are maintained appropriately.

Training.  This role is responsible to establish and maintain an effective personnel training system to ensure training requirements are established and maintained and training is conducted and documented in a timely and effective manner.

Corrective and Preventive Action (CAPA).  This role is responsible to establish and maintain an effective CAPA system to ensure existing and potential causes of nonconformances s are identified and addressed in an effective and timely manner.

Internal Quality Audit.  This role is responsible to establish and maintain an effective internal audit system to ensure the QMS complies with established QMS requirements and determine its effectiveness.

ESSENTIAL FUNCTIONS:

  • Ensures compliance with all applicable regulatory and corporate QMS requirements.
  • Manages direct reports and works closely with all other functions to maintain the suitability and effectiveness of the QMS.
  • Manage the CAPA activities in the Quality organization with responsibility for results in terms of quality system and product quality.  Maintain and continuously improve the CAPA program and ensure its effectiveness and compliance with applicable regulatory requirements.
  • Serves as subject matter expert for the Medina CAPA system. Identify and manage personnel involved in continuous improvement projects with the objective of achieving quality, reliability and system improvements.
  • Ensures the proper review and approval of all new and revised QMS documents prior to issuance including periodic review of documents for adequacy or necessary updates.
  • Establishes and maintains appropriate metrics and measures, including for document control, records management, change control and CAPA, and ensures data analyses is in accordance with applicable procedures to identify issues and trends to initiate and execute corrective and preventive action where indicated.
  • Supports external quality audits, including regulatory inspections, as the QMS subject matter expert and through provision of document control and records management services.
  • Manages the internal quality audit process to ensure audits are conducted when required by qualified individuals, corrective action is taken where necessary, audit results are documented and reported appropriately.
  • Ensures the efficiency, effectiveness and compliance of the document change control process, and that change control records/files are clear, concise and complete, and include documented premarket regulatory impact assessments where indicated.
  • Ensures all records (hard copy and electronic) are appropriately identified, and stored in a controlled and secure manner, and are retrievable in a compliant, efficient and timely manner.
  • Performs other duties as assigned.

QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED:

  • Extensive knowledge of relevant FDA, Health Canada and other international regulatory QMS requirements.
  • Demonstrated knowledge of current regulatory interpretations of QMS requirements and current industry best practices.
  • Ability to multi-task effectively.
  • Proficient in computer system use, including but not limited to Microsoft Office Suite and QMS software.
  • Strong analytical and problem-solving skills.
  • Ability to manage/supervise a team of employees.
  • Good communication and leadership skills.
  • Good interpersonal/communication/influencing/negotiation skills.
  • Good project management skills.

EDUCATION/EXPERIENCE REQUIRED (minimum):

  • BS degree in science or engineering. 
  • 5+ years experience in Quality, Manufacturing, Engineering or related field which should include 1-2 years of supervisory experience.
  • Minimum of 5-8 years of experience in Quality, or related field in the medical products industry.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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