Job Description
Job Description
Position Description: Document Control Supervisor
Reports to: Quality Operatins Manager
Direct Reports (Yes/No): Yes
Job Summary: Interact with cross-functional teams to coordinate, execute and maintain Quality System processes according to approved procedures. Lead Document Control and Quality Management System projects.
Duties/Responsibilities:
The Document Control Supervisor will coordinate a team of Document Control Specialists responsible for daily support activities related to knowledge management, document control, and the engineering change control process. Act as the subject Matter Expert (SME) for Quality Management Systems in IQMS including document control process, Bill of Material, IQMS QA module applications, and other quality processes quality system processes within IQMS.
- Consulting resource for new product and new customer quality system development including translating customer requirements into NXP QMS capabilities with construction of necessary protocols and reports to support product releases or engineering changes
- Maintain the document control system and assure compliance with applicable procedures.
- Ensures documents and records are accurate, complete and on time. Ensures processes for document and change control management are conducted per approved procedures and business rules.
- Schedule and assign the review and completion of workflows for controlled documents.
- Ensure that all documentation within the group is completed to the highest quality standards.
- Manage the archive system for all documents at the site.
- Creates and maintains organized files for master documents to support all documentation systems. Ensures timely retrieval of documents to support development, production and regulatory/customer audits.
- Assists with inquiries and training on the use of systems and processes associated with document and change control (ECN) processes.
- Actively engages in continuous improvement for areas of responsibility, collaborating with other departments to identify and implement process efficiencies
- Evaluate and work with other departments to reduce preventable deviations through procedure creation, revision, or process mapping.
- Oversee other Associates and Specialists responsible for daily support activities related to documentation control.
- Support customer audits and regulatory audits
- Develop and troubleshoot quality systems for new products and customers
- Key member of IQMS Center of Excellence.
Other duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Required Skills/Abilities:
- Familiarity with Document Management software tools is a plus
- Knowledge of FDA regulations (Quality System Regulations) and regulatory requirements such as ISO 13485.
- Ability to operate efficiently and effectively in a fast-paced environment
- Superior verbal and written communications
- Procedural or Technical writing experience, is a plus
- Knowledge of documentation practices and procedures
- Strong knowledge of configuration management in medical device manufacturing.
- Proficiency with Microsoft Office, especially Word, Adobe Pro, Excel, Outlook and PowerPoint
- Plan effectively and remain well-organized to ensure production schedules, regulatory and customer commitments are met in a timely fashion
- Ability to understand business processes and procedures needed for management of documents and records within a regulated environment.
- Experience with SAP, IQMS or similar ERP system is desirable
Education and Experience:
- Two-year technical degree in a related field, bachelor’s or related industry experience. preferred
- 10-12 years of related experience in manufacturing, preferably in the medical device industry or similar regulated environment
Physical Demands
While performing duties of the job, the employee is frequently required to walk.
The employee is occasionally required to lift/ or move up to 10 pounds