The Quality Manager (QM) supports manufacturing operations, new/revised product commercialization and material sourcing by using good manufacturing practice (GMP) systems to ensure production meets product quality specifications, validation processes, and quality system requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Achieves site objectives (quality assurance and operational) by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; assurance of quality and customer service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
• Manages timely and effective resolution and communication of customer complaints and internal rejections, completing root cause analysis and ensuring follow up actions are completed. Analysis of data / quality metrics for the on-going improvement of processes and products.
• Develops quality assurance plans by assessing risk; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
• Supports or leads validation initiatives to ensure quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
• Maintains and improves product/process quality by completing system compliance and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and associated manufacturing and training methods.
• Coordinates and leads internal and external audit-planning & management of all the requirements per ISO 13485:2016; acting in a lead role with customer and regulatory quality audits; carrying out internal audits and management of the audit schedule; completing customer related questionnaires/surveys.
• Responsible for supervising QA personnel, including hiring, interviewing, training, scheduling and performance evaluation.
• Other duties as assigned.

EDUCATION AND EXPERIENCE

• Engineering degree in a relevant discipline is required. Master’s degree is a plus.
• 5+ years as quality assurance manager or senior experience in a manufacturing environment (medical plastics is a plus) or equivalent combination of education and experience.
• Strong knowledge of ISO 13485:2016 or similar standard. Internal Quality auditor training is required. Certification is a plus.
• Strong understanding of statistics, measurement equipment, instruments and process validation.
• Six Sigma Black Belt certification is a plus.
• A background in plastic engineering is a plus.
• Exceptional attention to detail. Must be self-directed with leadership qualities.
• Ability to multi-task, work under pressure, and meet deadlines in a fast-paced work environment.
• Strong influencing skills, communication and interpersonal skills.