Site Quality Manager
Location: Augusta, GA
- Adopt the Right Mindset - When challenges arise, focuses on what s/he can solve. Maintains composure; is not defensive or irritated when challenged with adversity
- Lean Into Change - Open and adaptable to change. Effectively adjusts to changes and deals effectively with uncertainties. Actively leads through changes they see coming or wants to lead with energy, and confidence.
- Embrace the Difficult - Generates valuable ideas and effective solutions to difficult problems; action oriented, works hard to execute challenging tasks.
- Excellence with Integrity
- Understand the Business - Understands the big picture and impact of the work we do. Knows how the business works, and how to apply the regulatory and compliance rules.
- Anticipate and Solve Problems - Displays self-awareness and situational awareness, effectively anticipates future consequences and trends, comes with options and solutions for how to address risks and problems. Settles conflicts equitably in a professional manner, listens to opposing opinion, compromise.
- Choose ?We?? over Me - Has a one team attitude - we get the work done together, find solutions together. Has a well-rounded team of individuals with unique skills. Humble, collaborative.
- Care, Listen, Engage - Treats others with consideration, directly and indirectly. Listens to understand, asks how they can help, shares credit for work, and accepts responsibility for their work and work of their team.
- Invest in Relationships - Builds strong relationships, in and out of the site working to build trust. Gets to know on his/her team and site team. Builds productive relationships, has positive intent, coaches, mentors and develops others
The major activities of the Quality Manager are:
- Act as Management Representative for the facility.
- Oversees and has quality responsibility for the raw material facility.
- Responsible for Quality and Compliance Remediation activities at the Augusta, GA facility
- Lead, coach and develop all personnel within the Quality team to continually improve site quality performance, and manufacturing efficiency.
- Validation of product designs, manufacturing processes, equipment, and procedures required for the production and delivery of finished product.
- Establish systems and documentation required for the implementation and maintenance of a 21 CFR Part 820 total quality system and compliance to applicable International standards, such as ISO 13485 MDD/MDR, CMDR, etc.
- Coordinate effective management reviews, including gap analyses
- Coordinate training of the Quality System to Executive Management
- Support the maintenance of the associated product Technical Files
- Provide support and resources for the administration of Project Management, Design Control, Research, Development & Engineering efforts within the facility.
- Initiate and direct corrective actions to problems relating to product or process quality, such as complaint resolution, customer interface, regulatory action.
- Provide liaison between the operations management and regulatory agencies (FDA, ISO, DOH) regarding audit findings, litigation, and complaints.
- Support Risk Assessment techniques and methods (FMEA) in addressing design and improvement projects.
- Establish and implement quality systems that will support the key strategies for the plant with emphasis on continuous value improvements in total cost, quality, service, and innovation.
- Improve facility operations through implementations of quality management specifications, procedures, test methods, and measurement systems.
- Foster cross-functional integration of the Quality Organization with all other business unit functions by maintaining productive working relationships and promoting QA involvement.
- Manage departmental spending within the budget
- Support plant EH&S initiatives and foster safe working conditions in the department and the plant.
- This position requires a bachelor??s degree, preferably in a technical field relating to engineering or science.
- A minimum of five years (eight years, preferred) experience in the following areas: Quality Management & Regulatory Affairs, medical device or pharmaceutical manufacturing, FDA (CFR 820) and ISO/EC requirements, statistical techniques and sampling methods, root cause analysis, and problem solving. Experience in quality remediation, drug/device combination products, and cleaning validation is preferred.
- This position prefers certification as a Six Sigma Engineer, ASQ Quality Engineer, ISO Lead Assessor or ASQ Quality Auditor.
- Knowledge of applicable standards (i.e., ISO 13485:20016, MDSAP, MDD/MDR, QSRâ??s, and CMDR) and GMPs is required.
- Evaluate the impact of any new product or changes to existing products on regulatory applications.
Skills and abilities:
- Strong communication, multi-task management, organization, project management, and leadership skills are required for effective performance in this position.
- This position will serve in a results-driven environment and requires a team-oriented individual.
- The position facilitates team-based management, developing supportive relationships with all departments, functions, and personnel in dealing with quality problems, initiatives, and corrective actions.
- Manages quality department operations and supervises professional employees, frontline supervisors and/or business support staff, inspectors, and technicians
- Participates in the development of policies and procedures to achieve specific goals
- Ensures employees operate within guidelines
- Decisions have a short-term impact on work processes, outcomes, and customers
- Interacts with subordinates, peer customers and suppliers at various management levels may interact with senior management
- Interactions normally involves resolution of issues related to operations and/or projects
- Gains consensus from various parties involved