Site Quality Manager

Nationwide Technical and Executive

Dallas, TX

Site Quality Manager
Dallas, TX


Please call/text Sam at 248.890.6231 with any questions or you can email at sberi@nwexs.com. I can be reached anytime until 11pm any time zone.

* Candidate must be a Green Card Holder or US Citizen


Site Quality Manager will have the responsibility to manage and monitor the quality activities of manufacturing, supplier and customer operations.  This position will support personnel to ensure the attainment of goals set for overall quality assurance/control systems, quality managements systems and documentation, and overall quality reactive and proactive activities are met for the Dallas site.
RESPONSIBILITIES
List key responsibilities of the role.  These should not include RRE’s or KPI’s.
• Plans, coordinates, and directs quality assurance/control programs and help establish standards designed to ensure continuous production of products by performing duties.
• Review and evaluate inputs related to the Quality Management System for compliance and trends
• Directly supervise the Quality Team
• Manages department and overall expectations pertaining to priorities, budget, costs and resources
• Establish and maintain policy for documentation of all products
• Audits production facility to ensure compliance with applicable international standards and regulatory requirements, ISO 13485, ISO 22716, ISO 14971, QSR – 21 CFR 810, and GMP’s – 21 CFR 210/211.
• Monitor and advising the performance of the site quality management system, producing data, and measuring quality operations against set standards
• Review products, processes and systems on an ongoing basis to determine where improvements can be made
• Work with Quality, Supply Chain and operations to establish procedures, standards, and systems
• Work with Supply Chain and external suppliers to establish quality requirements for materials and components
• Work with operations and engineering to establish procedures, specifications, standards, and systems
• Manage the selection and development of people, resources, and budgets necessary to perform the functions of the department
• Trains workforce as required in various quality methods, standards and procedures
• Ensure Quality system effectiveness and conformance to industry standards and applicable international and regulatory requirements.
• Report to management on the effectiveness of the quality system.

VIRTUES AND TALENTS
The role incumbent will demonstrate the relevant talents for the role and will display the virtues aligned to our principles:
Essential
skills/experience/ qualifications: Essential skills:
• Must be able to present projects, findings, to a large group and interface with the group.
• Must have strong experience with writing procedures and standards
• Excellent problem solving, analytical skills and risk & crisis management.
• Must have excellent communications skills with internal and external customers.
• Able to lead and/or facilitate teams
• Experience in Quality Assurance and Quality Control
Essential technical experience:
• Knowledge of Validation (IQ, OQ, PQ) for Cleaning, Class 1/Class II Medical Devices, OTC Drug and Cosmetic products
• Experience managing a large staff
• Must have experience and knowledge of ISO 13485, ISO 14971 and 22716
• Must have experience and knowledge of 21CFR 820, 210 and 211
• Sterilization
• Lab testing – physical, analytical and micro
• New Product Development (Formulation Technology Transfer) and Design Control
• Hosting FDA, ISO and Customer Audits
• Water Systems, Environmental Monitoring, Stability programs
• MAV, AQL, Annual Product Review
Essential qualifications:
• Requires a Bachelor’s degree (B.A/B.S) in a technical field, chemistry preferred.
• Minimum of 10 to 12 years applicable/related experience in a decision making role for the Medical Device Industry, OTC Drug and Cosmetic product.  Preference some experience with liquid fill products – lotions, creams, gels, powders.
• ISO 22716 and 13485, QSR, 21CFR820, 210/211 and cGMP knowledge
- Self -motivated professional
- Driven individual with a strategic mindset


* Candidate must be a Green Card Holder or US Citizen


Please call/text Sam at 248.890.6231 with any questions or you can email at sberi@nwexs.com. I can be reached anytime until 11pm any time zone.