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Position Summary

The Senior Manager, Quality and Regulatory Assurance position is responsible for the implementation and execution of the Quality program for all products, raw materials, processes, and services. This position will work closely with all areas of the company; primarily Channel Management, Purchasing, Receiving, Manufacturing, Shipping, Sales, and Customer Support. In addition, this position works closely on the front line with our customers to ensure that our outstanding quality standards and costing initiatives are upheld.

The role will handle quality issues either directly with our customers or through our channel management team. The role is responsible for overall tracking and interpreting statistical data relating to quality; recommends changes in standards, processes, equipment, and materials to facilitate work and maintain quality. The role also interacts with supervisors to determine and resolve quality related issues.

Key Responsibilities

• Provide strategic leadership for the Quality Control Program to ensure all products, raw materials, processes and services meet the Company's exceptionally high-quality standards
• Ensure company compliance with accredited quality systems: 21 CFR part 820, ISO 13485, and applicable EU, UK, and Australian requirements
• Continue to strategically evolve company quality system as well as transition system with revisions of standards
• Acts as Management Representative and performs all duties and tasks associated with that designation. Acts a PRRC for European compliance.
• Lead company audits either by accreditation bodies or by customers
• Work with the appropriate teams to ensure proper action is taken and that the steps are initiated to avoid repeat errors.
• Maintain documentation and revision level of quality documentation for all products or services
• Maintain and communicate all quality data to department managers for problem identification, resolution, loss reporting
• Report company quality data including complaints, nonconforming product, and corrective/preventive action activities
• Review non-conformities (NCRs) for determining root cause, creating corrective actions, providing customer follow up and close NCRs within an acceptable timeframe
• Perform problem-solving tests to develop corrective actions for quality issues and to initiate continuous improvement
• Report Quality metrics and trends routinely to the company
• Conduct routine quality checks of product on the productions floor and report errors and process improvement recommendations
• Coordinate returns to vendors and ensure corrective actions are in place to prevent future defects
• Performs other duties as assigned.

Minimum Requirements/Qualifications

• Bachelor's degree from an accredited higher learning institution, preferably in a Quality or Engineering related field.
• Experience in high volume manufacturing environment, preferably in medical devices or in-vitro diagnostics
• Experience with European IVDD and IVDR compliance and regulations\
• Experience with FDA 21 CFR Part 820 regulations
• Minimum of 10 years' experience related to quality assurance, lean manufacturing, regulatory compliance, and/or Six Sigma manufacturing
• Holds Quality certifications in one or more of the following: ASQ/CQE, CMQ/OE, Six Sigma (Green or Black Belt)
• Hands-on approach to troubleshoot and resolve quality related issues
• Detail and Quality focused with strong organization, persuasion and negotiation skills
• Ability to present information and respond to questions from various levels within the organization
• Proficient in the use of MS Office
• Thrives in a fast-paced, collaborative environment, efficiently works under pressures, within deadlines or other time essential constraints.
• Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization.
• Strong work ethic and an ability to excel within a rapidly changing and growing organization.