Job Title: FDA Quality Compliance Manager
Department: Union City Quality
1. Job Description:
The FDA Quality Compliance Manager is an experienced person within the medical device industry with extensive knowledge performing their function within the Food & Drug Administration (FDA) Quality System Regulations (QSRs), International Organization of Standardization (ISO) 13485, Medical Device Directive (MDD) 93/42/EEC and ISO 14971. The incumbent has the ability to take strategic direction and establish efficient and compliant processes throughout the organization and has strong communication at all levels. The Quality Compliance Manager reports to the Executive Vice President of Union City.
2. Primary Responsibilities:
? Deputy Management Representative – Understand and perform tasks described within the Quality System for Management Representative duties.
? Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements.
? Upgrades and implements Quality Management Systems, drafting procedures or revising existing SOPs, and training teams for proper adoption of new system requirements.
? Managing the Internal/ External Audit process with internal customers and third party certification and regulatory bodies (FDA, FDB, Notified Body, etc.).
? Maintaining and organizing the company’s internal FDA quality audit program and managing corrective and preventive action plans.
? Employ quality assurance methodologies in support of Management, manufacturing and regulatory functions.
? Coordinates the Design Control projects in cooperation with the customers, including writing of internal product specification documents and directing phased Design Control activities if required by the customer.
? Active participant in all stages of design development, V&V testing and design control activities, ensuring quality assurance considerations and requirements met.
? Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation.
? Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications.
? Responsible for developing and maintaining sterilization validation and material biocompatibility activities, as applicable.
? Initiates and leads comprehensive Risk Management projects for compliance to ISO 14971, including: developing FMEAs, performing hazard analyses, and revising documentation as needed to support total product lifecycle considerations.
? Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance activities.
? Define quality control standards and test; specify test equipment and procedures.
? Helps establish and maintain test instrument calibration procedures and maintenance schedules.
? Identify quality assurance metrics; analyze and report trends to management.
? Review and host meeting(s) for nonconforming materials.
? Liaise with suppliers over quality issues.
? Assist in the failure investigation of product complaint and CAPA activities.
? Review for completeness and adequacy of the Design History record for the manufacturing builds.
? Initiates and coordinates all corrective action responses to the FDA for any variation notices.
3. Knowledge, Skills, and Experience (check all that apply):
? Education Level: Bachelor’s degree
? Experience: 5+ years of experience in the medical device industry
? Other Qualifications:
? Lead Auditor certification for ISO 13485 a plus.
? Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
? Familiar with EN 60601, Safety requirements for medical electrical systems.
? Familiar with ISO 62304, Medical Device Software – Software Life Cycle processes.
? Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents.
? Understanding of sterilization validation and material biocompatibility requirements.
? Understanding of software, electrical and mechanical Management principles.
? Excellent verbal and written communication skills.
? Effective problem solving skills.
? Ability to work in a team minded approach to achieve individual and company success.
? Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Excel, PowerPoint and Project programs.
? Demonstrated project management skills and experience.