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About the Role

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 manufacturing, validation, and post-market activities by implementing and maintaining quality systems that ensure product safety, efficacy, and compliance. The QA Manager collaborates with Operations, Facilities, Maintenance, and Supply Chain to drive continuous improvement and maintain compliance with FDA, ISO, GMP, and other applicable regulations.

Responsibilities

Develop, maintain, and improve the Quality Management System (QMS) in accordance with FDA, ISO, cGMP, and company quality standards.
Develop, review, and approve quality procedures, work instructions, and controlled documents.
Serve as the primary document and change control coordinator for the organization.
Initiate, investigate, and document product and process nonconformances and CAPA.
Act as the main quality representative for operational 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 investigation/documentation of 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.
Meet quality assurance financial objectives by estimating requirements, preparing an annual budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
Update 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.
Enhance 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.
Complete all required training and maintain required certifications.
Attend all assigned departmental and company meetings.
Represent JM Murray and the JM Murray mission in a positive manner, treating people with respect and dignity.
Perform additional duties and responsibilities as assigned.

Requirements

Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or Science required.
8 or more proven years of experience in Quality, Engineering, or a related field in a regulated industry (Pharmaceutical and/or Medical Device required).
Demonstrated experience with ISO 9001, 21 CFR 210/211, 21 CFR 820, and ISO 13485.
5 or more years of experience in interpreting regulations and translating them into quality system processes and procedures.
Must be able to work in an environment that includes noise, cold, heat, and odors.
Must be able to work in a position requiring exposure to weather conditions.
Must be able to lift unaided, at least 10lbs.
Must be able to lift unaided, from 11-30lbs.
Must be able to lift unaided, from 31-70lbs.
Must be able to lift unaided, from 71-100lbs.
Must be able to lift unaided, over 100lbs.
Must be able to write, type, and use office and/or other equipment and handle materials.

Skills

Strong technical writing skills.
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 of 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.
Proficient use of computers and other similar devices.

Location

On site
Travel to and work at any locations of operations

Work Type

Full time
On site

Experience Level

8 or more proven years’ experience in Quality, Engineering, or related field in a regulated industry
5 or more years of experience in interpreting these regulations and translating to quality system processes and procedures

Education Level

Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, engineering or science required.

Salary/Compensations

$29.98-$37.03/hour

Benefits

To explore the full range of benefits please visit our website www.jmmurray.com

About the Company

This job description is intended to describe the nature and level of work being performed by employees assigned to this position. It is not to be construed as an exhaustive list of all responsibilities and duties required of the job incumbents.
This position is designated as an FLSA exempt position.
Maintains attendance and punctuality in order to complete assigned duties.
Follows all quality and safety rules and regulations; wears and/or uses any required protective equipment while working; immediately reports any safety concerns or unsafe working conditions to QA and Operations Management.
Ensures compliance with all required regulations and guidelines in accordance with the JM Murray mission statement, policies and procedures.
Adheres to all professional standards and governmental laws, rules and regulations.
Reports any and all compliance related issues and concerns to the Director of Quality.
Manage the Company efforts in ISO to assure compliance against the International Organization for Standardization standards regarding all associated documentation.
Manage the Company efforts within the framework of the Food and Drug Administration (FDA) guidelines for products handled / produced by J.M. Murray Center, Inc.