Position reports to VP of Corporate Quality. Responsible for development and deployment of processes, standards and work methods that will deliver a world class QMS system encompassing Greenville operations, customers and suppliers.
- Develop and deploy a roadmap for QMS that encompasses current state to future state. Roadmap should consist of key areas of improvement, migration from backend inspection to built-in quality and key areas of customer value that can be the basis of monetizing services.
- Plant Quality System Compliance to the most current applicable FDA and ISO13485 requirements.
- Participates in audits for compliance to customer and regulatory/GMP/ISO requirements.
- Submit any required data and documentation to applicable Regulatory Agencies such as FDA for Drugs and Medical Devices to comply with current FDA regulations to maintain compliance – such as labeling and product listings.
- Review each product and confirm with Customer if there is a specific requirement for; UDI (Unique Device Identifier) or Serialization and communicate immediately.
- Responsible to confirm whether or not the product requires Sterilization and if so, what type, what method, who is responsible for charges associated with Sterilization – and communicate with MPS team, establish Sterilization validation and Dose Audit as required.
- Responsible to assure each Product is assigned correct Classification in Syteline Inventory system
- Assist Quality Engineer with IQ’s, OQ’s, PQ’s, Cleaning Validations, Calibration program
- Review, approve, track, trend and report on Validation Protocols, Deviations, Customer Complaints, CAPA’s
- Leader of ISO 13485 compliance for plant. Responsible to help departments and responsible employees to achieve compliance with items in their respective department. (For example: Work with Maintenance Manager to assure PM Program will pass audit and is in compliance)
- Perform Review of new or revised Master
- Oversight of the CAPA Corrective and Preventive Action program to ensure documentation of investigation, Root Cause conclusion, respond to customer, trending, “Effectiveness Verification” completion.
- Create and update a variety of correspondences and memos. Gather data to create complex reports including charts, graphs, tables and spreadsheets for review and approval.
- Oversee/Lead Internal Audit program.
- Oversee/Lead Supplier Audit program.
- Assist in investigation of Quality complaints and out of specification events. Monitor any corrective actions that result from investigations.
- Attend internal and customer meetings to communicate questions, concerns, and updates with processes and products as needed.
- Represent the company in a positive and professional manner during regular customer and vendor site visits.
- Participates in yearly budgetary process and develop Quality measures.
- Perform other duties as assigned.
- Ability to read, understand, and interpret FDA regulations and ISO standards.
- Ability to read, analyze and interpret batch records, audit records and letters.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, customer auditors, and members of the business community.
- Ability to factually document events and findings.
- Ability to effectively present information to top management and corporate representatives.
- Knowledge of Microsoft Office (to include PowerPoint, Word, Excel, Access and Project)
- Minitab experience is preferred
Other Required Skills and Abilities:
- Knowledge of Good Manufacturing Practices, ISO 13485, 21CFR Parts 10, 11, and 820
- Validation Experience with packaging equipment IQ/OQ/PQ.
- Excellent interpersonal, presentation, and business communication skills.
- Detail oriented; ability to catch mistakes.
- Quick learner and creative problem solving skills.
- Excellent organizational skills.
- Ability to react quickly to unexpected occurrences.
- Requires positivity, initiative, and self-motivation.
- Ability to work independently with minimum supervision.
- Ability to work on a team and exchange ideas.
- Ability to make company minded decisions based on ethic, effort, and reliability.
Licenses, Certifications, Registrations:
- CQE, CQA, Six Sigma and/or Lean Certifications preferred.
- Willingness to attend applicable skill building and training seminars and events as requested.
- Working conditions are normal for a manufacturing environment and an employee must be able to successfully perform these functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to regularly sit, talk, hear, stand, walk, and use hands and arms to manipulate, handle, reach and feel. Work may involve lifting of materials and product up to 40 pounds. The noise level in the office and the packaging floor is low to moderate, respectively.