ADDMAN Polymer Multi-Site Quality Manager

About the role

The Quality Manager at ADDMAN Precision will apply knowledge in the implementation of an integrated Quality Management System (QMS) to ensure full compliance and a continual product, process, and supplier improvement culture. This individual will work closely with all cross-functional teams to create quality strategies that support customer needs and overall business objectives. The role involves solving difficult problems relating to the quality aspects of design, validation, and manufacture of medical devices, and serving as owner and administrator of several aspects of the quality system, including supplier management, customer feedback, process control, internal audits, change management, and design control. This position is subject to the International Traffic in Arms Regulations (ITAR) and requires U.S. person status.

Responsibilities

• Plan, implement, and direct quality program consistent with ISO and AS9100 quality systems
• Maintain and communicate quality objectives complementary to corporate policies and goals
• Maintain a working knowledge of government and industry quality codes and standards
• Assist in daily quality related requirements on the shop floor, such as in-process and final inspection of parts and assemblies
• Develop and direct internal audit program, customer audits, certification audits, and audits of vendors/suppliers
• Resolve issues and non-conformances found during audits
• Lead investigations of customer complaints and ensure corrective actions are implemented in a timely manner
• Communicate with customer as required
• Lead investigations of internal non-conformances and ensure root cause corrective actions are implemented in a timely manner
• Lead efforts to reduce quality issues including corrective action, preventive action, and supplier quality concerns
• Ensure purchases of materials meet customer requirements
• Work with Manufacturing and Quality Engineers in the preparation of Quality Data Packets
• Take an active role on the quality control team and lead the team in document and data control
• Promote a positive and professional work environment
• Lead and record company’s quality management review meetings
• Serve as the liaison with third-party auditing and evaluation organizations
• Monitor the approved supplier and supplier evaluation processes
• Manage the process integrity, data collection processes, and reporting to senior management
• Oversee the customer satisfaction and evaluation process
• Monitor laboratory processes and effectiveness
• Utilize Six Sigma quality tools, when appropriate, to define, measure, analyze, improve, and control processes and outcomes
• Maintain and support processes, procedures, and KPIs owned by the position

Requirements

• Bachelor’s degree in industrial management, quality management, or related field
• Three to five years of related experience and/or training; or equivalent combination of education and experience
• Effective interpersonal and communication skills
• Experience with ISO and/or AS9100 quality systems, quality planning, and mechanical inspection
• Previous supervisory experience in a quality function preferred
• Organizational and analytical skills
• Ability to read and interpret documents, write reports and correspondence, and convey appropriate messages to vendors, customers, and employees
• Ability to manage risk and resolve conflict
• Ability to resolve complex manufacturing problems and troubleshoot manufacturing/production systems
• Ability to apply knowledge of mechanical engineering, machining, metrology instrumentation, and experimental techniques in developing customer solutions
• Experience and knowledge with ASME Y14.5
• Experience with PC-DMIS
• Experience with Global Shop Solutions or other ERP system
• Experience with special processes (e.g., plating, welding, heat treat)
• Knowledge of laser, CMM, and vision systems
• Experience with supplier certification and supplier quality planning
• ASQ or similar professional certification
• Working knowledge of quality improvement tools, including Six Sigma

Pay

Salary Exempt – $100,000 to $135,000