Quality Assurance Manager

Other duties as assigned

Note: Management reserves the right to assign or reassign duties and responsibilities to this job at any time.

The requirements listed in the sections that follow are representative of the knowledge, skills and/or abilities required to perform the duties of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions (primary duties) of the job.

• Bachelor’s degree in a scientific or engineering field — Common majors include Quality Assurance, Engineering, Food Science, Microbiology, or related disciplines.

• Advanced training in FDA QMSR / ISO 9001 — Professionals often complete specialized FDA and ISO 9001 training programs to understand regulatory alignment and inspection expectations.

Certifications (beneficial but not always required)

Certified Quality Auditor (CQA)

Certified Quality Engineer (CQE)

Internal/Lead Auditor credentials

• 5–10+ years of QA/QC experience in regulated manufacturing require QA experience in FDA‑regulated or ISO‑certified environments.
• Experience with FDA 21 CFR — Managers must understand and maintain compliance with FDA’s Quality Management System Regulation, including design controls, CAPA, complaint handling, and production controls.
• ISO 9001 Quality Management System experience includes internal audits, supplier audits, document control, and risk management.
• Experience hosting or supporting FDA and ISO audits require experience preparing for and participating in FDA inspections and ISO 9001, FSSC audits.

• Leadership experience — Supervising QA teams, inspectors, or cross‑functional groups is required.

• Strong CAPA, root‑cause analysis, and nonconformance management skills — Essential for maintaining compliance and driving continuous improvement.

• Experience with supplier quality and external audits.

While performing the duties of this job, the employee is typically required to have the ability to work in an office environment, using office equipment as needed, read, write, listen, speak, and understand English, follow instructions and other oral/written information, compose correspondence in a professional manner, complete paperwork and other documentation accurately, work independently and with others, communicate effectively with all individuals internal and external to the organization, analyze information/situations as needed, be organized and detail-oriented, be able to identify/judge the urgency of a situation, use judgment in decision making and use creativity and negotiation when necessary.

On a frequent basis, there may be exposure to plant areas, which include exposure to outside weather conditions as well as loud noise from equipment and dust from production processes.  This includes walking up flights of stairs in the production areas.

The employee is expected to be self-directed, take initiative and be persistent when appropriate to accomplish necessary duties and keep busy without prompting.  Additionally, the employee is expected to be adaptable/flexible to changing work assignments, have a high level of integrity, dependability and self control to maintain composure, perform multiple tasks at once, learn and memorize procedures, manage time effectively and efficiently, meet established deadlines, display a cooperative attitude, read, understand and follow all ISO, company, job specific and safety policies/procedures, and attend/use all required training. 

Safety Equipment:  Safety equipment required while performing the duties of this job includes an ANSI approved hardhat and safety glasses, safety shoes/boots with steel toe protection.

Safety Training:  A new employee hired to perform the duties of this position is required to be provided New Employee Training by a qualified individual which consists of a total of 24 hours of training. 

Additional refresher safety training will be required as management deems appropriate or as dictated by MSHA/OSHA regulations.