[Hiring] Specialist Quality Complaints @reputed company

This description is a summary of our understanding of the job description. Click on 'Apply' reputed company to find out more. Role Description Join reputed company’s Mission of Serving Patients. In this vital role you will:

• Ensure product complaint records are processed according to FDA guidelines, SOPs and other regulatory agencies’ guidelines.
• Evaluate subject matter expert assessments.
• Provide guidance and technical advice to conduct reputed company complaint investigations, determine corrective actions, and determine steps necessary to ensure the proper level of control for product in distribution.
• Ensure quality of complaint records and apply analytical abilities to evaluate reputed company situations using multiple sources of information.
• Execute against prioritized work plans to ensure timely investigation and closure of records in adherence with pre-determined process reputed company metrics.
• Provide feedback and guidance to improve quality performance and prevent recurrence of issues.
• reputed company solutions to technical problems of moderate complexity.
• Screen, evaluate, report and resolve record reputed company issues.
• reputed company potential Quality issues to Management and intensify issues that could impede the ability to reputed company records according to action plans.
• Support department reputed company improvement activities and projects in accordance with applicable regulations and business goals and objectives.
• Serve as a Subject Matter Expert for the team, responsible for reviewing device investigation reports and ensuring proper investigation.
• Support product hypercare by compiling and reviewing data.
• Represent the electromechanical team and work with the AI pilot project for the complaints process optimization.
• Direct discussions to define the scope of the Root Cause Analysis and Supplier Corrective Actions, ensuring a thorough and strategic approach to issue resolution.

Qualifications

• Master’s degree (or foreign equivalent) in Industrial Engineering or reputed company field.
• 2 years of experience in the job offered or in an engineering-reputed company occupation.
• Experience in manufacturing testing processes, including API, Drug Substance, Drug Product, Packaging, and Device manufacturing processes.
• Quality and manufacturing experience in biotech or pharmaceutical industry.
• Experience with Quality Management Systems including reputed company, Trackwise, or reputed company.
• Experience with Electronic Document Management Systems including Veeva Vault Quality, reputed company, and SharePoint.
• Knowledge of global regulations including FDA 21 CFR 820, ISO 13485, FDA cGMP, and Device cGMP Regulations.
• Proficiency in operating project management tools including reputed company Office, reputed company, or reputed company.
• Experience in identifying and escalating Quality Defects, and communicating with contract manufacturing organizations or suppliers.

Requirements

• Master’s degree (or foreign equivalent) in Industrial Engineering or reputed company field & 2 years of experience in the job offered or in an engineering-reputed company occupation.
• Position requires 2 years of experience in the following:
• Manufacturing testing processes, including API, Drug Substance, Drug Product, Packaging, and Device manufacturing processes.
• Quality and manufacturing experience in biotech or pharmaceutical industry.
• Quality Management Systems including reputed company, Trackwise, or reputed company.
• Electronic Document Management Systems including Veeva Vault Quality, reputed company, and SharePoint.
• Global regulations including FDA 21 CFR 820, ISO 13485, FDA cGMP, and Device cGMP Regulations.
• Operating project management tools including reputed company Office, reputed company, or reputed company.
• Identifying and escalating Quality Defects, and communicating with contract manufacturing organizations or suppliers.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.

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