Overview
Quality Technician/ QMS Coordinator Jobs in Houston, TX at SEG MANUFACTURING INC
Quality Manager
Full or Part Time
Pay from $80,000 per year (full time)
Flexibility for Remote/ In Office as needed
Job Overview:
We are a small tissue banking and processing facility looking for a Quality Manager with a background in cGMP, and preferably cGTP, as well as familiarity with FDA and AATB requirements for cellular and tissue-based products.
The Quality Manager will be responsible for continuous development and oversight of all quality activities pertaining to the safety, consistency, and quality of our products. This includes developing, implementing and maintaining quality programs, policies and procedures, to improve product quality and ensure products are produced in compliance with cGMP, cGTP and FDA regulations. In addition, the Quality Manager will be required to interact with both internal and external customers, as well as quality and regulatory agencies.
Essential Duties and Responsibilities:
Accountable for the development of quality assurance plans and systems to ensure commercial manufacturing and development programs remain compliant with all applicable regulations and guidelines
Leads regulatory agency interaction related to compliance
Establishes, monitors, and provides progress of the Quality KPIs
As the management representative, ensures the electronic Quality Management System is implemented and maintained
Lead facility readiness for all third party audits including notified bodies.
Produce release documentation for each lot of finished product
Accountable for the final disposition of product
Works with R&D and Manufacturing departments in the development, scale-up, and testing of new products, processes, and equipment
Manage statistically significant sampling plans, in-process quality checks to insure safety and quality.
Generate, review or approve Quality Assurance related documentation required for customer relationship/product development (such as: development, supply and quality agreement), verification of compliance, or for filings with regulatory bodies.
Oversee Document Control and lead Change Control systems.
Responsible for Raw Materials Supplier Qualification activities including the supplier audit program.
Maintain all current facility certifications along with scoping and adding additional certifications.
Organize and ensure the completion of all product investigations, Non-Conformances, OOS’s, and CAPAs
Preferred Knowledge, Skills and Abilities:
Regulatory Experience
Significant experience (5+ years) in medical device/pharmaceutical manufacturing, quality assurance, regulatory affairs, or a related field.
Experience in regulatory compliance management
Familiarity with FDA and AATB requirements.
FDA/ AATB audit experience
Communication
Excellent organizational and interpersonal skills.
Strong computer skills, including quality management software
Ability to work within a team environment, as well as independently, with minimal supervision.
Adaptability
Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
Able to coordinate/manage multiple tasks simultaneously
Job Types: Full-time, Part-time
Pay: $80,000.00 per year
Expected hours: 20 – 40 per week
Ability to Commute:
Scottsdale, AZ 85262 (Required)
Ability to Relocate:
Scottsdale, AZ 85262: Relocate before starting work (Preferred)
Work Location: Hybrid remote in Scottsdale, AZ 85262
Title: Quality Technician/ QMS Coordinator
Company: SEG MANUFACTURING INC
Location: Houston, TX
