QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Manages internal and/or external customer complaint investigations.
• Maintains control of the site metrics for complaints, internally or externally.
• Manages the evaluation of customer complaints, triggers, and provides suggestions for process/product improvements.
• Supervises the day-to-day area activities, including Complaints, Additional evaluations, Triggers, FARs, FAR preliminary investigations, Field Actions, among other.
• Generate open complaint report and follow up on each complaint / task owner on a daily basis.
• Ensure that the complaints area comply with all GMP, regulatory, corporate and internal requirements regarding housekeeping, safety, etc.
• Assure all documentation performed in the area is complete, accurate, and in compliance with the procedures, specifications and regulations.
• Assure all complaints samples evaluation are performed according to the applicable SOPs and Specifications.
• Supervises and manages task prioritization in the complaints area and Final Physical.
• Perform evaluations to the returned units as per individual specifications, BOM's, blue print, etc.
• Perform data collection, and monthly trending of product hospital complaints for key indicators and Management Review.
• Ensure appropriate actions are driven by complaints conclusions.
• Statistical Process Control (SPC) monitoring to identify areas for improvement.
• Gather, analyze, and interpret data using SPC methods so as to be able to predict trends and recommend process.
• Assure that all machinery, equipment, tools or any other measuring, monitoring material complies with SOPs, specifications, GMP and other regulatory requirements.
• Promote a zero-harm work place and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed.
• Observe confidentiality and data privacy rules at all time.
• Evaluate the Quality Data Review (QDR) results to identify actions to be implemented.
• Be a facilitator of Manufacturing and Quality Improvement projects.
• Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.
• Submit changes (improvements and/or modifications) to specifications and Standard Operating Procedures.
• Responsible for review changes in specifications and SOP's under CDR system.
• Provide support and/or manage non-conformance investigations (NCR, CAPA, etc.) and NCRs related to the Complaints.
• Interact under minimal supervision with various Local and Divisional function groups.

Qualifications:

• Bachelor's degree in Science or Engineer discipline. Other bachelor's degrees may be considered if it is commensurate with experience in Quality Assurance, Quality Control or Documentation Center.
• 5 years of experience in related area.
• Experience in Medical device industry preferred
• Must have the ability to manage people, encourage teamwork and drive decisions.
• Excellent verbal and written communication skills.
• Knowledge of statistics is preferred.
• Proficiency in computer software such as Microsoft Excel, PowerPoint, Word, or similar tools.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.