Quality Assurance Mgr

J.M. Murray Center•Cortland, NY

1d•Onsite

About The Position

The Quality Assurance (QA) Manager is responsible for ensuring that medical devices and pharmaceutical products comply with applicable regulatory requirements, quality standards, and company procedures. This role supports the manufacturing, validation, and post-market activities by implementing and maintaining quality systems that ensure product safety, efficacy, and compliance. The QA Manager works cross-functionally with Operations, Facilities, Maintenance, and Supply Chain to drive continuous improvement and maintain compliance with FDA, ISO, GMP, and other applicable regulations.

Requirements

Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, engineering or science required.
8 or more proven years’ experience in Quality, Engineering, or related field in a regulated industry – Pharmaceutical and/or Medical Device required.
Must have demonstrated experience with ISO 9001, 21 CFR 210/211, 21 CFR 820 and ISO 13485
5 or more years of experience in interpreting these regulations and translating to quality system processes and procedures.
Strong technical writing skills. Must be able to clearly document investigations, change control, etc.
Strong technical, analytical, and problem-solving skills.
Ability to coordinate with management on courses of action with minimal assistance using both written and verbal methods.
Good interpersonal/communication/influencing/negotiation skills.
Good project management skills.
Working knowledge of FDA Regulations & ISO 13485 and Application of Good Manufacturing Practices.
Must be able to provide solutions that reflect understanding business objectives and cost implications.
Capable of working in a team-based setting providing direction and knowledge
Proficiency in Microsoft Office Suite, including EXCEL and data entry with proficient use of computers and other similar devices

Nice To Haves

ASQ Certified Quality Engineer (CQE)
ASQ Certified Quality Auditor (CQA)
Six Sigma Green Belt or Black Belt
Lead Auditor certification (ISO 13485)
Experience with ERP and electronic QMS systems

Responsibilities

Develop, maintain, and improve the Quality Management System (QMS) in accordance with FDA, ISO, cGMP, and company quality standards.
Responsible for developing, reviewing, and approving quality procedures, work instructions, and controlled documents.
Serves as the primary document and change control coordinator for the organization.
Initiate, investigate, and document product and process nonconformances and CAPA.
Main quality representative responsible for operation activities such as batch record approval, Master Production/Control records and production documentation.
Monitor manufacturing processes for compliance and effectiveness.
Develop, execute, summarize, and approve validation plans/reports including; Process Validation, Product Validation, Product/Process Verification, Cleaning Validation (pharmaceuticals) and Test Method Validation.
Support test method processes including; procedures, test methods and material management, manage the stability program and documentation.
Support all supplier management activities including; qualification, supplier audit, and investigate/document supplier quality issues.
Support management reviews and quality metric reporting.
Conduct internal quality audits and support external audits by regulatory agencies and customers.
Support inspection readiness activities and corrective action implementation.
Investigate customer complaints and product quality issues.
Support adverse event reporting and post-market surveillance programs.
Meets quality assurance financial objectives by estimating requirements, preparing an annual budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
Updates job knowledge by studying trends and developments in quality management, participating in educational opportunities, reading professional publications, maintaining personal networks, and participating in professional organizations.
Enhances department and organization reputation by accepting ownership for accomplishing new and different requests, exploring opportunities to add value to job accomplishments.
Develop working relationships with departmental personnel to ensure open communications regarding any quality-related concerns / ideas
Completes all required training and maintains required certifications; attends all assigned departmental and company meetings.
Represents JM Murray and the JM Murray mission in a positive manner, treating people with respect and dignity.
Performs additional duties and responsibilities, as assigned.