Descripción del Trabajo
This position has the responsibility and authority to lead assigned Quality System processes. In addition, this role will lead customer audits, and regulatory/compliance audits and/or inspections, support software implementation (regulatory impact) and when required prepare submissions and responses to FDA and ISO Registrars. Responsible for the development, recovery and maintenance of the documentation related to the CAPA and Complaint Management System and Regulatory Compliance.
ESSENTIAL DUTIES AND RESPONSIBILITIES
CAPA/Complaints System Handling activities:
- Responsible for leading CAPA/CC’s activities including coordination/management of overall CAPA/CC’s impact analysis, and Product Field Action Coordination and execution.
- Ensures regulatory compliance and optimization of quality system procedures relating to CAPA/CC’s development and implementation of employee training, and development and implementation of quality metrics to drive improvement and business results.
- Coordinates and maintains accurate investigation information CAPA/CC’s Files: Reviews documentation, ensures that CAPA/CC’s documentation is of acceptable overall quality, technically accurate, understandable, and correctly completed.
- Facilitates, documents and distributes minutes from the CAPA/CC’s Review Meeting(s) and status cross-functionally to all departments and work cells.
- In conjunction with the Purchasing Department, follow up suppliers on raw materials’ non- conformances investigation responses, in order to determine if event is to be escalated as a Supplier Corrective Action Requests.
- Performs and document corrective actions effectiveness reports for closure for CAPA/CC's systems.
- Maintains the CAPA/CC Trackers and NWQS CAPA/CC's database updated per current action step.
- Provides training on Root Cause Analysis Techniques, Jabil Healthcare NWQS Action Applications module and procedures for CAPA and CC’s Handling to system users.
- Responsible for periodic CAPA/CC’s Metrics and trending reports distribution to Management, such as: JOS Meetings, MRB Meetings, Monthly Operational Review and Management reviews.
- Incumbent is mainly responsible for the receipt and processing of complaints documentation in the NWQS System. This includes notification to internal parties and acknowledgement to customer.
- Requests, receives, and analyze and/or coordinates the analysis of complaint’s samples to confirm the non- conformance.
- Coordinates Complaint related material disposition, including Return authorization and/or Scrap onsite authorizations and material receipt at Jabil Healthcare for timely disposition and resolution.
- Generates and maintains the outstanding CAPA's/CC’s responses and action items to monitor and track for timely completion and submission to customer.
- Communicates with customers, as necessary, in relation to outstanding complaints, keeping the customer informed of the status of the complaints.
- Coordinates and participates 2nd and 3rd party audits as required external audits and FDA inspections.
- Initiates ACA (audit corrective actions) for non-conformances and follows up for timely closure.
- Facilitate audit non-conformances evaluation and response team meetings for timely resolution.
- Generates Management Review presentations.
- Present metrics (ie: Key Performance Indicators) to management regarding the performance and effectiveness of the quality system.
- Evaluates, makes recommendations, and implements improvements to the quality system as part of continuous improvement activities.
- Supports the Purchasing Department in the supplier’s performance management (supplier quality monitoring results records control, SCAR issuance & management).
- Supports the Purchasing Department, by participating in the site’s Supplier Evaluation Files approval process, SAP’s Quality Info Records maintenance as requested
- Assists with the maintenance of the site Quality Management System through assessment of functions and processes and identifying areas for improvement or increased compliance, derived from the CAPA/CC’s systems.
- Participates as part of the Internal Auditors Team.
JOB QUALIFICATIONS / KNOWLEDGE REQUIREMENTS
- Excellent interpersonal, written, and verbal communication skills especially with Power-point
- Fully Bilingual (Spanish/English; oral-written)
- Knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21CFR PART 820, 21 CFR PART 11, GAMP 5, ISO 13485, MedAccred)
- Ability to correlate QMS performance with product and process quality trends
- Some experience with compliance assessments, gap assessments and risk management assessments.
- Experience with program change management practices, lean or six sigma, program and system integration efforts
- Strong computer skills including experience with presentation preparation utilizing MS office or similar tools and Database applications
- Strong interpersonal skills are required. Must be an effective team player intra-departmentally and cross-functionally.
- Strong leadership, collaboration and relationship building skills. Must be able to work in a team environment, influence change without alienating others.
- Results oriented, with the ability to interact with technical and non-technical personnel
- Ability to analyze data, drive root cause using analytical and/or statistical tools
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Organized self-starter and pro-active approach combined with excellent time-management skills
- Bachelor’s degree required (Quality, Regulatory, Engineering, Business or Life Sciences)
- Master’s degree is desired (Quality, Regulatory)
- 6 + years of industry experience within Quality and/or Regulatory
- American Society of Quality, Certified Quality Auditor (CQA) credentials, is preferred.
- Or a combination of education, experience and/or training.
- Regular business hours. Some additional hours may be required outside normal working hours
- Climate controlled office environment during normal business hours.