What you will do:

This role will support our Peripheral Vascular (PV division) and is an onsite role in Irvine, CA. In this role, you will be responsible for operations activities related to the manufacturing of medical devices. You will also be responsible for producing, tracking, and managing the associated metrics, including Quality, Customer Service, Cost, People Development, and Innovation. You will focus on leading the team to create the Quality First Culture and meet quality expectations, drive Lean effort and team engagement to meet the overall business result, and provide business growing support such as manufacturing transfer and new product development. Additional responsibilities include:

• Lead, oversee, coordinate, and facilitate the activities in a production area ensuring safety, quality, and compliance while achieving production goals, efficiency and yield targets and cost objectives.
• Manage self and team in a manner that demonstrates a primary commitment to patient safety, product quality and compliance with the Stryker, Quality Manual, and its governing regulations. Ensure product is manufactured to the most current/validated method/process and specification and DHR for every lot is correctly filled in per GMP & QS requirements.
• Proactive capacity management(Staffing and equipment) with associated inter-disciplinary coordination. Make budgetary recommendations on capital expenditures and direct labor resource planning.
• Work with planning team Ensure appropriate build scheduling and execute to meet customer requirements.
• Ensure traceability and inventory accuracy/control including components, sub-assemblies and finished goods.
• Provide strong supervision of human resources including recruiting, interviewing, hiring, development and performance management,improve the organization capability for the responsible area.
• Lead the team create a respect, open communication, positive and collaborative work environment.
• Lead or participate Continuous Improvement projectsby leverage Lean Light house, Kaizens, and other lean methodology to improve quality, increasing capacity, improving efficiency, reducing scrap improve space utilization and other activities as business needs.
• Ensure equipment, tools, fixtures, gages and measuring devices are effectively used, maintained, and calibrated in responsible area.
• Interactwith Manufacturing Engineering, Equipment Engineering, Quality, and materials colleagues to drive results with highly efficiency and effectiveness.
• Participate in quality systemsaudits (i.e., internal & external)
• Participate in budget process and manage the budget implementation for the responsible area.
• Must have ability to lift 50 pounds routinely; 75 pounds occasionally.

What you need:

• Bachelors degree in a technical or business-related discipline.
• 4+ years' experience in business, operations, or manufacturing, preferably in medical device or other highly regulated industry.
• Working knowledge & understanding of general Quality System & ISO 9001 requirements.
• Working knowledge and understanding the overall business process from material receiving to finish goods shipping.
• Ability to read, analyze and interpret general business periodicals, professional journals, and technical procedures. Ability to author reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions. Must have the ability to communicate and understand technical terminology.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Must have the ability to resolve daily production problems.
• Understanding of team dynamics, and ability to maximize organizational results.
• Self-starter with the ability to accomplish tasks with minimal supervision.
• Demonstrated effective interaction skills across multi-disciplinary functions (lateral & upward/downward).
• 3+ years' experience in a supervisory role preferred.
• Lean/Six Sigma experience preferred.
• System experience such as NetSuite, SAP, MES preferred.

$102,700 - $171,100 USD