Quality Manager - Medical Devices - Raland Compliance Partners

 Our client is seeking a hardworking and enthusiastic Quality Manager to join our Plant Quality team and help us drive operational excellence and a culture of quality and compliance throughout our facility. The Quality Manager is the designated site Quality Management representative and responsible for all Quality aspects at our client's Inland Empire, CA manufacturing site. This position reports into Corporate Director, Quality Operations with dotted line reporting to the Plant Manager. 

 THE ROLE Drive Plant Performance in Quality, Delivery, Cost and Customer Service 

• Drive 'quality is a service' thinking and partner with Plant Management Team and other key stakeholders to improve quality, delivery, cost, and consumer service metrics for the plant. 
• Lead and manage Quality Function at the site. 
• Build, lead and manage a high performing team of subject matter experts and supporting resources to deliver functional and business objectives. 
• Interface with customers for various customer requests, projects, issues, and audits. 
• Represent site to customers and external authorities for various audits as well as related quality and regulatory topics. 

Manage and improve Key Corporate and Site QMS Processes 

• Coordinate with Corporate Quality and Plant Management to manage and improve quality procedures/processes for better 'operational quality' on the plant floor 

Provide Quality Control, Metrology, Quality Engineering and Validation support to Operations, Engineering and Quality Teams 

• Support day to day operation projects, troubleshooting and continuous improvement 
• Stand-up, operate and maintain necessary Quality Control and metrology labs. 
• Develop and conduct DOE's, statistical analysis, capability studies etc. for qualifications, troubleshooting or process improvements. 
• Develop and execute on qualifications protocols 

Execute Audit and Compliance Program 

• Collaborate with Corporate Quality for continuous improvements to the Audit & Compliance Program. 
• Own ongoing execution of the Audit & Compliance program to improve compliance with the procedures and standards, successful completion of the audits and ensure audit readiness at all times 

Promote a culture of Quality Awareness and Employee Engagement in the QMS 

• Train, coach, motivate and develop plant teams in the areas of Quality Improvement, Quality Policy, Measurement and Analysis, Quality Metrics, Customer Satisfaction (NPS) and Quality Systems/ISO requirements. 
• Develop Quality department performance goals and objectives. 
• Own Organization Planning and other HR processes for the site Quality organization. 
• Develop communication and training plans for Quality Awareness and Engagement. 

• Bachelor's degree from four-year College or University in Business, Science, Engineering, or a related field; 7+ years of hands-on Plant Quality Operations or Quality Management Systems (QMS)implementation experience 
• Thorough knowledge of regulated Industry, CFR Part 820 Quality System Requirements, MDSAP program, the ISO family of standards, particularly ISO 13485 and ISO 9001 
• Experience in plastics processing technologies serving the packaging, pharma, and medical device markets. 
• Experience with training, validation processes and Statistical Process Control (SPC). 
• 3+ years of experience in managing team of salaried and/or hourly employees. 
• Certifications: Quality Management or Quality System Auditing, i.e., ASQ CQM/OE or CQA 

DO YOU HAVE?? 

• Excellent data entry skills, using Microsoft word, Excel, IQMS or similar ERP and Quality Management System. 
• Excellent organizational skills with demonstrated attention to detail. 
• Strong mentoring and coaching skills. 
• Strong written and oral communication skills. 
• Strong analytical skills with an ability to take science based, data driven decisions. 
• Ability to interface with customers as well as external authorities and represent the our client's core values 
• Ability to interact with individuals at all levels of the organization, including communication of complex work products and priorities in straightforward terms. 
• Self-motivated, excellent leadership qualities with ability to manage various technical resources. 
• Ability to work in a fast-paced manufacturing environment with demonstrated ability to handle and prioritize multiple tasks and demands.