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Form of workJob Description
Job Title: Quality Assurance Manager
Location: Waco, TX
Position Type: Onsite
Work Hours: Monday-Friday, 8 AM to 5 PM
Position Type: Onsite
Work Hours: Monday-Friday, 8 AM to 5 PM
Salary: 95000-130,000/year DOE
JOB OPPORTUNITY: Quality Assurance Manager
Are you a dynamic professional with a passion for ensuring top-notch quality in a fast-paced environment? We have an exciting opportunity for a Quality Assurance Manager.
QUALIFICATIONS:
- Bachelor's degree in science or equivalent.
- 5+ years of experience in regulatory affairs, product development, or product manufacturing in a managerial capacity.
- Six Sigma Certification is a plus.
- Lean Manufacturing Certification is a plus.
- ISO Lead Auditor Certification is a plus.
RESPONSIBILITIES:
- Spearhead the overall effectiveness of our Quality Program.
- Act as the go-to representative for regulatory bodies, including FDA and ISO.
- Ensure compliance with 21 CFR 820 and establish and maintain Quality System requirements.
- Develop a comprehensive Quality Plan outlining practices, resources, and activities for company products.
- Lead initiatives for robust supplier quality and conduct audits.
- Establish and manage an Internal Audit program.
- Oversee the Material Review Board (MRB) process.
- Conduct Management Reviews with the Senior Management Team at predetermined intervals.
- Manage the Corrective and Preventive Actions (CAPA) system.
- Supervise quality department personnel to ensure timely completion of objectives.
- Manage both receiving and production inspection processes.
- Uphold compliance with cGMP standards and adhere to the Site Quality Policy.
SKILLS AND ABILITIES:
- High organizational skills.
- Ability to thrive independently in a high-pressure environment.
- Advanced knowledge of ISO 13485 and 21 CFR 820.
- Proficiency in Microsoft Excel, Word, and Outlook.
- Strong communication and problem-solving skills.
APPLY AT WWW.SEDONASTAFFINGTX.COM
