Quality Assurance Mgr

Job Description

Job Description

Job Title

Quality Assurance Manager

Reports to

Director of Quality

Direct Reports

None at this time

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.

Full time 

To explore the full range of benefits please visit our website  

$29.98-$37.03/hour - Placement in the range will be determined based on experience and other factors allowed by law. 

GENERAL SUMMARY

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.

COMPANY STANDARDS

• Maintains attendance and punctuality in order to complete assigned duties. This position performs work functions on site but may also travel to and work at any locations of operations.
• 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.

ESSENTIAL FUNCTIONS

1. Develop, maintain, and improve the Quality Management System (QMS) in accordance with FDA, ISO, cGMP, and company quality standards.
2. 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.
3. Initiate, investigate, and document product and process nonconformances and CAPA.
4. Main quality representative responsible for operation activities such as batch record approval, Master Production/Control records and production documentation.
5. Monitor manufacturing processes for compliance and effectiveness.
6. Develop, execute, summarize, and approve validation plans/reports including; Process Validation, Product Validation, Product/Process Verification, Cleaning Validation (pharmaceuticals) and Test Method Validation.
7. Support test method processes including; procedures, test methods and material management, manage the stability program and documentation.
8. Support all supplier management activities including; qualification, supplier audit, and investigate/document supplier quality issues.
9. Support management reviews and quality metric reporting.
10. Conduct internal quality audits and support external audits by regulatory agencies and customers.
11. Support inspection readiness activities and corrective action implementation.
12. Investigate customer complaints and product quality issues.

1. Support adverse event reporting and post-market surveillance programs.
2. Meets quality assurance financial objectives by estimating requirements, preparing an annual budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
3. 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.
4. Enhances department and organization reputation by accepting ownership for accomplishing new and different requests, exploring opportunities to add value to job accomplishments.
5. Develop working relationships with departmental personnel to ensure open communications regarding any quality-related concerns / ideas
6. Completes all required training and maintains required certifications; attends all assigned departmental and company meetings.
7. Represents JM Murray and the JM Murray mission in a positive manner, treating people with respect and dignity.
8. Performs additional duties and responsibilities, as assigned.

COLLABORATION

INTERNAL 

• JM Murray Management and Administration
• JM Murray Operations employees and trainees

EDUCATION and EXPERIENCE

• 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.

PREFERED QUALIFICATIONS – Preferred but not Required

• 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

KNOWLEDGE and SKILLS

• 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

This section is intended to be blank.

WORKING CONDITIONS

Job assignments take place primarily indoors but also outdoors when traveling to pick up supplies, attend meetings or to work at other JM Murray locations. Environmental conditions include rain, snow and cold weather.

PHYSICAL REQUIREMENTS

Job-related physical abilities an individual must possess in order to perform the job in a satisfactory manner. In some cases accommodations may be made in accordance with JM Murray policy and with our mission.

0-24 %

25 -49 %

50 -74 %

75 –100 %

Standing/Walking/Mobility: Must be able to stand to operate equipment; mobility to embark and disembark from equipment.

X

Environmental Conditions: Must be able to work in an environment that includes, but is not limited to noise, cold, heat and odors. 

X