Quality Manager

Job Summary:

The Quality Manager is responsible for the day-to-day operations of all quality activities, as defined by the quality management system, ISO 9001 requirements, current and future certifications/accreditations, and customer requirements. The Quality Manager is responsible for providing support and guidance to the quality associates. This key position will advise leadership on necessary continuous improvement efforts so that systems and processes are in line with overall company strategy, voice of the customer, regulatory standards, guidelines, and quality policy. The QM provides technical input, advises, and implements necessary process and documentation changes. This position works with the team members to execute all products and services for the platform.

Supervisory Responsibilities: Quality Team Members

Duties/Responsibilities:  Your responsibilities as a Quality Manager will include but not limited to:

• Manage the process to inspect, test and evaluate single use assemblies and products 
• Track products through the manufacturing process to guarantee that each part of the process is correct
• Perform detailed and recorded inspections of final products so the products are up to industry and company standards
• Develop detailed data analysis and action plans related to customer quality performance including Voice of the Customer
• Identify and evaluate product and system problems that could adversely impact the quality of products, processes, or services. Lead resolution of these problems, solution development, and execution.
• Ensure that relentless root cause analysis permanently solves customer complaints
• Ensure Quality Management System’s modules/functions are being used to control/monitor/record interactions with our external customers, nonconforming material, corrective actions, audits, document control, training, calibration, preventive maintenance, and FMEAs
• Demonstrate progress by tracking appropriate quality performance metrics in line with the tactical actions and trends against the long-term quality strategy.
• Develop and maintain an audit system to monitor compliance to the Quality Management System, customer requirements, regulatory requirements, and applicable quality standards requirements.
• Develop strong working relationships with internal and external cross-functional teams to drive quality-centric continuous improvement at all levels of the organization
• Develop strong working relationships with all customers and suppliers. Support customer and supplier business teams to assure that quality expectations are achieved
• Manage the responses to customer questionnaires, certification requests, and surveys
• Support customer audits and function as the quality contact for customer and supplier questions 
• Participate as the Change Control Board Member for Quality  
• Participate in Drawing Review Meetings as the Quality point of contact
• Prepare and approve material specifications for raw materials, distributed products, and other HPNE products
• Prepare and approve SOP that support the quality process
• Perform thorough batch record review prior to accepting product lot for release
• Developing a strong quality organization. This includes coaching, mentoring, growing, and developing talent.
• Teach the use of the appropriate quality tools to assist continuous improvement efforts

Required Skills and Abilities:

• Successful candidate will have a broad Quality and/or Engineering background, with direct experience in customer management, contract review and implementation, and quality management systems 
• Strong business acumen
• Strong interpersonal, oral, and written communication skills
• Facilitation and teaching skills, particularly across functions 
• Strong self-initiative and the ability to work independently to achieve results
• Strong organizational development and teambuilding skills• Ability to manage all audit requirements including leading internal audits and providing representation during third party assessments 
• Strong proficiency in corrective action processes and root cause investigation/analysis
• Strong grasp of manufacturing systems and processes
• Excellent organizational skills and attention to detail 
• Experience with reading engineering drawings 

Education and Experience:

• Bachelor’s Degree in a life science discipline, or an equivalent combination of education and experience
• ASQ CMQ/OE, CQA, or other relevant certifications preferred
• 5-10 years progressive work experience in quality systems, combined with a demonstrated record of accomplishments as a quality professional with strong customer orientation in a similar industry; previous supervisory experience required
• ERP experience preferred
• Proficient with Microsoft Office Suite 
• Knowledge of cGMP regulations experience in a clean room environment
• Cleanroom experience required

If you are interested, please apply or send resume confidential to jeff.welter@gogpac.com

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