Quality Manager

Quality Manager The Quality Manager is responsible for the facilitation and oversight of all Quality Department processes and personnel. The position will take a key leadership role in ensuring customer satisfaction and identifying a driving corrective and continuous improvement initiatives to our product, QMS, and business processes. Primary Job Responsibilities LMA (Leadership, Management & Accountability) QMS strategy and adherence Oversee the Quality Management System (QMS) strategy and adherence. Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented. Oversee and ensure compliance with the ISO 13485, and FDA registration to conform to all applicable laws and regulations. Ensure proper training procedures are developed and assigned to appropriate personnel in all departments related to quality. Implement root-cause analyses and other problem-solving activities to identify effective corrective actions and process improvements. Ensure the quality control resources are adequate, efficient and effective for problem identification, resolution, loss reporting. Ensure metrics are established and implemented for monitoring system effectiveness and to enable managers to make sound product quality decisions. Analyze customers' product specifications to establish efficient, cost-effective requirements for ease of manufacture and reproducibility. Make equipment recommendations for use in the quality lab; understand and train how to use the equipment to perform quality measures accurately and efficiently. Participate in internal and external quality audits. Other duties as required. Requirements Bachelor's in Engineering or closely related discipline. Two (2+) years managing direct reports; five (5+) years of quality/engineering activities in a medical device environment or related manufacturing experience. Skills & Knowledge Leadership and Management of people, processes, projects. Statistical methods (SPC). Excellent problem-solving skills. Ability to lead a team effectively. Ability to communicate using a common language understood by engineers, customers and/or executives. Excellent oral and written communication skills with an emphasis on listening to others. Ability to formulate a plan and execute. Visualize what the customer wants and using detail-orientation follow a plan to get there. Mathematical and statistical knowledge. Exercise good judgment when dealing with people as well as projects. Ability to present ideas to larger audiences. Ability to delegate when appropriate. Management principles. Microsoft Office suite. Plastics and tooling industry. General office equipment, including computers, printers, telephones, copier, etc. General manufacturing and office procedures. Working Environment & Physical Demands Normal manufacturing environment The employee is required to sit, move about, reach, handle and feel. Visual Acuity as required, with or without accommodation, for reading written documents and computer screens. Hearing ability as required, with or without accommodation, for listening, monitoring and responding to machines and equipment and for communicating with customers, co-workers. Benefit Overview Medical Insurance (ICHRA): Tax-free employer contributions through an Individual Coverage Health Reimbursement Arrangement (ICHRA), with contribution amounts based on age and coverage level. Coverage begins the 1st of the month following 30 days of service. Dental & Vision Insurance: Optional plans available with affordable monthly premiums. 401(k) Retirement Plan: Automatic enrollment at 4% after 90 days of employment, Company match available and full vesting after 4 years. Company-Paid Coverage: Life insurance, Short-term disability, Long-term disability and Employee Assistance Program (EAP). Optional Benefits: Supplemental life insurance, Legal and identity protection plans This benefits package is designed to help employees and their families maintain their health, build financial security, and achieve peace of mind. Equal Employment Opportunity Dynamic Group is an equal opportunity employer committed to fostering a diverse, inclusive, and equitable workplace. Employment decisions are made based on qualifications, merit, and business needs. We do not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, or any other legally protected status. Dynamic Group celebrates diversity and is dedicated to creating a workplace where all employees feel valued, respected, and supported.