Position Summary:

• Provide oversight and subject matter expertise in handling change orders, complaints, non-conformances, CAPAs, variances in accordance with site specific and corporate procedures as well as current US FDA and international regulations.
• Review, evaluate, and investigate product and process non-conformances relative to the identity, quality, safety, and effectiveness of medical products.
• Identify, generate and publish metrics and reports related to the change orders, complaints, non-conformances, CAPAs, variances issues.
• Follow-up internally and externally to assure compliant, complete, and accurate files for change orders, complaints, non-conformances, CAPAs, variances, and product performance information.
• Support change orders, complaints, non-conformances, CAPAs, variances in internal and external audits and inspections.

Major Responsibilities:

• Ensure records (e.g., completion of investigations, risk assessment, review and/ or creation of documentation) associated with change orders, complaints, non-conformances, CAPAs, variances are adequate, accurate, detailed and timely.
• Collaborate with appropriate Technical, Clinical, Field/Sales, Operations and R&D resources to ensure assigned tasks are completed on time.
• Provide guidance to personnel to complete tasks compliantly, correctly, and timely, where the incumbent is accountable for the task.
• Analyze and report data using spreadsheets, graphs, and databases.
• Elevate issues to management as appropriate.
• Drive continuous improvement of the Quality System.
• Perform other duties as required

Minimum Requirements/Qualifications:

• Bachelors’ degree or relevant experience with an Associate’s degree in clinical/medical discipline, engineering or science.
• 5 - 7 years related experience in a regulated environment; preferable with medical devices or pharma.
• Knowledge of applicable international regulations and standards (CFR, IVDR, QSR, ISO 13485, ISO 14791, etc.).
• Medical device experience is a must.
• Non-Conformance and CAPA investigation experience is a plus.
• Regulatory and Quality Management knowledge and skills.
• Must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective.
• Previous experience in legal, technical or medically related area preferred.
• Must have demonstrated ability to think strategically and be able to prioritize multiple tasks.
• Self-motivated and is able to work with little guidance for routine tasks
• Demonstrated ability to manage multiple activities and tasks.
• Demonstrated use of quality tools methodologies and strong computer skills.