Senior Supervisor, Quality

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

The Quality Senior Supervisor leads our Quality Inspection teams in Components, Tissue, Solutions, Preliminary Packaging, and Valve Assembly areas of the Irvine Implant Manufacturing facility. The role provides oversight for daily operations, non-conformance management, and new product transfers, partnering closely with Manufacturing, Engineering and Supply Chain.

• Supervise employees and quality activities pertaining to the production of products and/or manufacturing processes in - and with quality /technical knowledge of - multiple production areas, depending on the complexity of the areas, in addition to conducting performance reviews, including resolving performance issues, providing feedback, all hire/fire authority, and partnering with HR on all aspects of employee of employee.
• Lead complex improvement projects, partner with engineering on investigations and/or corrective actions, perform non-conformance investigations for review with engineering, assures documentation content is valid.
• Provide regular progress reports and manufacturing metrics to management and cross-functional stakeholders, including developing resolutions as needed to improve metrics achievement while accountable for productivity and quality metrics of staff.
• Establish the scheduling of work orders and team performance metrics, including monitoring output and adjusting schedules to ensure production targets are achieved.
• Document owner for assigned product line inspection procedures.
• Responsible for all project outcomes of assigned unit/group of employees.
• Other incidental duties.

• Bachelor's Degree in-depth technical knowledge and experience in assigned work area, and substantial experience in related manufacturing, quality and/or product development engineering, with skill levels exceeding the requirements of the Supervisor II or equivalent work experience based on Edwards criteria
• 4 years previous related experience with full responsibility for all personnel including hire/fire authority and handling all aspects of employee relations in manufacturing, quality and/or product development engineering or equivalent work experience.

• Ability to supervise, lead, and/or mentor employees in a fast-paced manufacturing environment with experience fostering multi-cultural teams with cultural sensitivity.
• Proven expertise in both Microsoft Office Suite and Enterprise Resource Planning (ERP) system, preferably JDE.
• Experience working in a medical device industry, preferred.
• Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives, enhance job expertise and awareness of company policies for GMP, SOP and safety regulations, as well as mediating and negotiating the needs of other areas to achieve consensus.
• Full understanding of all aspects of processes and equipment used across areas of responsibility.
• Ensure testing conforms to appropriate standards of identity, strength, and quality of components and in process products.
• Knows and effectively uses fundamental concepts, practices, and procedures relative to quality and productivity improvements.
• Must be able to develop creative solutions to challenging problems; adept and experienced problem solver who is capable to determine root cause of technical issues and implements effective solutions in a timely manner
• Able to understand statistics, engineering drawings, Bills of Materials, and operational procedures.
• Knowledge of Lean Manufacturing concepts, SPC, Process Map, DFMEA/PFMEA and Six Sigma.
• Adhere to all…