Position Overview:

Responsive Respiratory is seeking an experienced, dynamic and detail-oriented Test & Compliance Manager to implement and oversee product quality assurance, testing, regulatory compliance and post market surveillance programs. This role will maintain the documentation of process flows for the company to ensure products are tested efficiently and that the quality management system remains compliant with applicable regulatory bodies. Specific Duties include but not limited to: Develop, implement and maintain testing procedures, requirements and quality control processes for new and existing products Manage and supervise testing operations to meet production schedules and quality targets Analyze production and testing data to identify trends, bottlenecks, and improvement throughout Investigate failed or out-of-specification test results and coordinate corrective actions Monitor workflow, staffing, and equipment utilization to maximize productivity and efficiency including the training and oversight of assembly/testing technicians and production staff Validate testing equipment to ensure calibration and maintenance is performed on a regular basis Maintain Quality Management System to ensure compliance, including documentation related to production processes, testing records, and operational metrics Audit process flows and quality management system (QMS) for process adherence and gaps. Identify and implement corrective actions, as necessary Participate in internal and external audits, inspections, and quality reviews as needed Manage and support CAPA, nonconformance, and change-control investigations related to testing and compliance issues and present regular updates to management team Monitor regulatory updates to applicable standards, regulations and certification requirements to ensure company practices remain compliant

Requirements:

Bachelor's degree in engineering, manufacturing, industrial technology or related discipline 5+ years of experience in manufacturing, assembly or testing operations 2+ years of supervisory or management experience Experience interpreting technical standards and regulatory requirements Strong understanding of manufacturing processes, quality systems and testing procedures Experience with ERP/MRP systems and production reporting tools Excellent leadership, communication and critical thinking skills Knowledge of Lean Manufacturing and continuous improvement practices preferred

Preferred Qualifications:

Working knowledge of FDA Regulations (21 CFR Part820) Understanding of

ISO-80601-2-67

2020 quality standards Strong analytical and organizational abilities Proficiency in Microsoft Office and manufacturing software systems Ability to read engineering drawings and technical specifications

Company Benefits:

Salary range: $120,000+ based upon applicant's experience 401(K) matching after 1 year as defined by company policy Health/Dental as defined by company policy Paid Time Off;

Paid Holidays About Us:

Responsive Respiratory develops and markets a comprehensive line of high-pressure oxygen equipment and accessories including regulators, cylinder carts & racks, and carry cases for the Home Healthcare, Emergency Medical, and Hospital markets throughout the United States. The corporate culture sets us apart from the competition as we go to great lengths to support customers with an exceptional, friendly, and knowledgeable customer service group.

Visit website:

respondo2.com

Benefits:

401(k) matching Dental insurance Health insurance Paid time off Retirement plan Application Question(s):

NOTE:

This role is in the office with anticipated time of 8:00AM-5:00PM Do you have experience with FDA or ISO regulations? If yes, provide additional details and level of proficiency. Do you have experience with development and implementation of a quality management system (QMS)? Rate your experience in drafting and updating internal corporate policies: Beginner/Intermediate/Expert Do you have experience with New Product Implementation? If yes, please provide additional details.

Work Location:

In person