Systems Compliance Supervisor

Role Purpose

Reporting directly to the Plant Quality Manager, responsible for ensuring the plant complies with ISO 13485, MDD 93/42/EEC and FDA requirements; facilitates audit programs for all facets of the manufacturing process, including internal, supplier and ISO/FDA; supports systems for the processing of product complaint reports and Help Desk Tickets to ensure timely closeout; and quality improvements and recommends and implements collaborative systems solutions. 

Responsible for the development of the QMS team members in maintaining a high-performance work team culture and focusing on the plant goals of safety, quality, schedule and cost. Provide central quality professional support for day-to-day plant systems support.  Develop and improve quality systems, i.e., quality records, engineering change control, corrective and preventive actions, and customer complaints.  Support quality systems improvement projects using broad-based quality, engineering, and technical skills, e.g., diagnostic and corrective action skills.  Maintain quality metrics. 

Responsibilities

• Lead improvements in product quality and systems compliance.
• Assist with activities to ensure customer complaints are closed in a timely manner. 
• Manage the Corrective Action/Preventive Action (CAPA) system for the plant using the problem-solving tools. Ensure compliance with Division CAPA program. 
• Responsible for managing reports responsible for Document Control and Training system. Responsible for the Document Control and Training systems at the plant. Ensure compliance with Division Document Control and Training programs. 
• Developing team members' knowledge and application of quality systems to provide consistent high performance.
• Develop technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO.
• Training support to product teams for Good Documentation Practices and policies/procedures as required.
• Function as a contact for FDA/ISO/Corporate/Division/Customer audits and inspections and ensures plant compliance with plant quality/regulatory requirements.
• Function as a contact for and oversee compliance for all customer audits and inspections and ensures plant compliance with plant quality/regulatory requirements.
• Manages internal auditing program; schedules, plans, and completes audits, and verifies effectiveness of corrective actions; selects, trains, and reviews performance of lead auditors and audit teams.
• Responsible for providing support with the supplier management program, including auditing, control and improvement of suppliers. Responsible for overseeing Supplier Audit Program from quality perspective.
• As a member of the Quality support group, facilitates team meetings and provides guidance for team members.
• Supports various projects, including new product/process, cost reduction and quality improvement efforts.
• Support the Regulatory Compliance team to address/improve issues related to Class I and Class II medical devices. Manage changes and updates to the Class II medical devices Technical File. 

Requirements

• BS Degree (microbiology, biological sciences, life sciences or engineering preferred)
• Five-plus (5) years of Quality experience, preferably in a health care, pharmaceutical or related industry.  
• Strong knowledge and understanding of quality system regulations/requirements (i.e. ISO 9001, ISO 11137, ISO 13485, ISO 15378, ISO 14644, 21 CFR Part 210/211, Part 820, and cGMP/GLP and USP requirements).