- Responsible for the Quality Systems functions including Document control supervision, Internal audit, Customer audit, Records retention, Management Review
- Provide expertise and guidance for site document control practices specific to a regulated medical industry.
- Supervise, train, motivate and document control staff
- Serve as a gate keeper for all controlled site documentation throughout document life cycle
- Responsible for the daily operation of the site Document Control activities/deliverables
- Serve as the Document Control subject matter expert(SME) for the site
- Oversee the Jabil healthcare Clinton/Devens Internal audit program, Record Retention program, Management Review
- Administers Internal audit Program-Plans, manages, communicates, and documents internal audits.
ESSENTIAL DUTIES AND RESPONSIBILITIES ·
- Assistance to establish and maintain compliance to Quality System standards and regulations that apply to the manufacture of medical devices in the United States and the rest of the world(i.e., ISO 13485,FDA 21 CFR, Part 820, Quality Systems Regulation,etc)Execute working knowledge of document control practices by completing/processing day-to-day departmental requests/tasks
- Serves as the first line of contact in the case of escalated Document Control related issues/concerns.
- Establish and maintain a Document control department capable of effective, efficient, timely and consistent customer(internal/external) service delivery. Manage team members workload and priorities to support business needs.
- Oversee staff work performance and administers performance reviews annually
- Directs and monitors Quality Systems and Regulatory Affairs records and documentation to ensure adequate retention period maintained and dispositioned
- Provides assistance to ensure that adequate Job descriptions and training requirement matrix per Job descriptions exists, are updated and made available.
- Develops and Maintains the Internal Quality audit program. Ensures completion of the Internal quality audit plan. Reports Internal audit plan status to Management on a periodic basis.
- Host and support external audits as needed
- Supervises consolidation of weekly, monthly, quarterly, annually required KPI metrics and coordinates Management Review Meetings.
- Participate in problem-solving and process improvement activities.
- Support all programs and initiatives related to the Jabil Healthcare Ethics code, Values and Sustainability programs.
- Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position
- Bachelor’s degree in Management, engineering, Science – or related discipline preferred
- 5-8 years of medical device or pharmaceutical industry experience. Knowledge of ISO 13485 and FDA part 820.Proven Supervisory/Managerial experience
- Excellent attention to detail, follow through and organizational skills
- Must be self-motivated and able to work independently with minimal supervision/guidance
- Demonstrated working knowledge of document control practices and requirements in a regulated medical device manufacturing environment (21 CFR Part 820,21 CFR Part 11, ISO 13485, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP),etc)
- Auditor certification -ISO 13485:2016
- Ability to exercise sound judgement and decisions on behalf of the department
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