Quality Assurance Coordinator - Healthcare jobs in Santa Ana, CA

Nikkiso Clean Energy & Industrial Gases is a leading provider of cryogenic pumps, heat exchangers, process systems, services, and solutions for the LNG and industrial gases industry. We are a subsidiary of Nikkiso Company Ltd, a leading industrial manufacturer headquartered in Tokyo, Japan, with over $1.5 B in annual revenue, 8000 employees worldwide, and publicly traded on the Tokyo Stock Exchange.

Nikkiso ACD is an engineering and manufacturing company specializing in machinery designed to operate at cryogenic temperatures as low as – 420 degrees Fahrenheit, the boiling point of Liquid hydrogen. For over 50 years, Nikkiso ACD has specialized in centrifugal and reciprocating pumps as well as turbines for air separation. Nikkiso ACD has the most diversified product line in the industry covering nearly every application requiring pumps or turboexpanders.

This position is based at Nikkiso ACD located in Santa Ana, CA.

Manager, Quality Assurance

Summary/Objective

The ACD Quality department is responsible for ensuring our products and services meet or exceed customer expectations through the deployment and continuous improvement of the Quality Management System. The team of Quality Engineers, Technicians and Document Control Clerks partner with internal and external stakeholders to measure performance, qualify only the highest quality vendors, consistently calibrating company procedures to support the design, manufacture, assembly and export of high-quality engineered products.

Essential Functions/Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Responsible for leadership and effective and efficient management of the Quality Department personnel;
• Responsible for optimization of the Management Systems in compliance with international regulations such as ISO 9001, and IEC 80079-34;
• Lead cross-functional development/deployment, and maintenance of tactical objectives and KPIs;
• Maintain Quality objectives and KPIs related to Receiving Inspection, In-Process and Final Inspection, MRB, Supplier Quality Performance Index, Project Quality performance, Cost of Quality, Internal (First Party) and External (Second and Third Party) Audits; Corrective Actions, Field Trouble Reports/Customer Complaints;
• Responsible for assuring an effective and efficient quality operations such as Quality Assurance and Control, Continual Improvement, Project Quality and Regulatory Management;
• Analyzing, identifying, and implementing manufacturing and/or business process improvements which will improve capability and performance;
• Lead RCCA – CAPA programs and initiatives, including Trend Analysis/Pareto Charts, DMAIC etc.;
• Responsible for tracking the cost of quality and implementing actions to reduce failure and later assessment cost of quality;
• Plan quality for products and projects by use of quality control plans, inspection and test plans ITPs, work orders/travelers, and MRP;
• Responsible for integration of Quality Assurance through entire phase of Project Realization (e.g., from proposal/award to closure);
• Actively work with the Procurement department to optimize Supply Chain;
• Acquire and maintain product line certifications, specifically Maritime Class Societies (e.g., ABS, BV, DNV, LR) Product/Manufacturer approvals;
• Design and deploy various types of First Party Audit programs, occasionally conduct suppliers’ audits in coordination with the Procurement department, and represent the company in case of Second- and Third-party assessments;
• Continually evaluate and improve methods for tracking VOA and customer’s satisfaction and launch improvement actions as necessary;
• Coordinate with Marketing/Sales, Engineering, Procurement, Production, and Project Management functions to detect and reduce risks related to the Regulatory Compliance, Project Schedule/Scope/Quality/and Cost;
• Promote Risk and Process Based approach across the organization, deploy SIPOC model, PDCA;
• Promote and work on implementation of Kaizen Events, 5S, Kanban, Lean Manufacturing and Lean Supply Chain;
• Troubleshooting problems or quality issues related to products or processes;
• Meeting with members of the production team to offer recommendations and share results;
• Maintaining and controlling calibration records for test and inspection equipment;
• Applying good manufacturing practice and observing that it is being adhered to;
• Performing tests and measurements using existing measurement equipment;
• Verify parts and products are compliant to specifications;
• Defines quality procedures in conjunction with operating staff;
• Collaborates with other members of management to develop new product requirements and manufacturing and training methods;
• Develop and deploy Training Program for Quality Department, and assure that other departments deploy applicable training programs.

Supervisory Responsibilities

Manages and develops a team of quality assurance professionals, providing coaching and mentoring to enable them to reach their full potential.

Work Environment

• Job will generally be performed in an office environment, but may require travel to a client's office, production facility or industrial/construction job site. Conditions will vary at each location, but the conditions listed above will generally apply

Physical Demands

• In order to perform the duties of this job, the employee may be required to stand, walk, sit, reach with hands and arms, climb or balance, stoop or kneel, talk and hear, and use fingers and hands to feel objects, tools or controls
• Overtime may be necessary as the work load's dictates. This may include weekdays, weekends, nights and/or holidays
• The ability to lift up to 40 pounds is required
• A valid driver’s license is required for travel between the ACD facility locations as required

Education and Experience

• Minimum bachelor’s or university degree in Engineering (Mechanical, Material, Electromechanical);
• ASQ certification (e.g., CMQ/OE) is preferred;
• 5 years’ experience in a Quality leadership or management role within a manufacturing environment.

Knowledge and Critical Skills/Expertise:

• Demonstrated knowledge of ASME section VIII, ASME Section IX, PED, ASTM regulations;
• Sound mathematical and technical skills;
• Good investigative and problem-solving skills with excellent attention to detail;
• Ability to think logically and methodically;
• Good interpersonal skills and organizational skills;
• Excellent verbal and written communication skills;
• Negotiating, supervisory and leadership skills combined with the ability to delegate;
• Decision making ability coupled with the ability to work independently and proactively;
• Knowledge of statistical packages and Microsoft Office systems normally required;
• Dimensional inspection experience of machined components;
• Previous exposure to a machine shop, foundry, or sheet metal shop;
• Proficient in Microsoft Office Word, Excel, and PowerPoint;
• Quality System auditing and reporting experience;
• In depth working knowledge of ISO 9001 standard;
• Understanding of standard manufacturing and safety compliance processes.

Salary

$110,000.00 - $135,000.00 per year

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Equal Opportunity Employer/Veterans/Disabled

Nikkiso CE&IG is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.