Quality Manager - Manufacturing
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Job Location:
Phenix City - USA
Yearly Salary:
$ 80000 - 90000
Posted on:
28-08-2025
Vacancies:
1 Vacancy
Job Summary
Salary: $80000 - 90000/year
We are seeking a highly experienced and detail-driven Quality Manager to lead quality assurance and quality control functions in an FDA-regulated manufacturing environment. The ideal candidate will ensure compliance with cGMP FDA ISO 13485 (if applicable) and other regulatory standards while driving continuous improvement across the organization. This role is critical to ensuring product safety efficacy and regulatory readiness.
Responsibilities
- Oversee daily operations of the Quality Assurance (QA) and Quality Control (QC) departments.
- Ensure compliance with applicable FDA regulations (21 CFR Part 210/211 820 etc.) ISO standards and internal SOPs.
- Lead and manage audits and inspections by the FDA ISO registrars and customers.
- Develop implement and maintain the companys Quality Management System (QMS).
- Review and approve deviations CAPAs change controls and nonconformance reports.
- Monitor key quality metrics (e.g. batch failures complaints audit findings) and present trends to senior leadership.
- Oversee validation and qualification activities (e.g. equipment process cleaning and software validation).
- Support training programs to ensure staff are fully trained on quality procedures and GMP requirements.
- Collaborate cross-functionally with manufacturing R&D supply chain and regulatory affairs.
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
Requirements
- Bachelors degree in Life Sciences Engineering or related field (Masters preferred).
- Minimum 3 years of quality experience in an FDA-regulated manufacturing environment (e.g. pharmaceutical medical device biotech or food).
- At least 3 years in a management or leadership role.
- Strong knowledge of cGMP 21 CFR Part 210/211 or 820 and relevant FDA regulations.
- Experience with QMS implementation regulatory inspections and audit readiness.
- Excellent problem-solving and root cause analysis skills (e.g. CAPA FMEA 5 Whys).
$80000 - $90000 a year
Required Experience:
Manager
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
Latitude 33 Aviation is SoCal's premier company for private jet charter, aircraft management, and aircraft sales. Contact us today for more information!
