Quality Manager

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

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

• Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; assurance of quality and customer service standards / procedures; identify and resolve problems related to quality of product; complete audits; determine system improvements; implement changes.
• Meets quality assurance financial objectives by estimating requirements; schedule expenditures; analyzing variances; initiating corrective actions.
• Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification of effectiveness.
• Validates 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 quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
• Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
• Manages timely and effective resolution 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.
• 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.
• Provides quality system induction training for new employees and ensures training updates related to new or revised SOPs.
• Manages the Quality Management System (QMS). Responsible for supervising QA personnel, including hiring, interviewing, training, scheduling and performance evaluation. Other duties as assigned.

EDUCATION AND EXPERIENCE 

• Bachelor’s degree in a relevant discipline is required.
• 5+ years as quality assurance manager or senior experience in a manufacturing environment within a regulated industry, or equivalent combination of education and experience (Medical device experience is a plus)
• ISO 13485:2016, Internal Quality auditor training is Certification is a plus.
• Strong understanding of statistics, measurement equipment, instruments and process validation.
• Evidence of using root cause analysis tools.
• Six Sigma Black Belt certification 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.

We offer a full complement of valuable Health, Wellness, and Welfare benefits which include:

• PTO & 8 Company Holidays
• Medical, Dental, and Vision.
•  Life and Disability.
•  401(k) and Match.
•  Wellness Program including EAP.
•  Pay for Performance philosophy.