Job Description

POSITION SUMMARY:

The Senior Quality Engineer at Dinsmore in Irvine, CA will work to apply knowledge in the implementation of an integrated Quality Management System (QMS) to ensure full compliance and a continual product, process, and supplier improvement culture. This individual will work closely with all cross-functional teams to create quality strategies that support customer needs and overall business objectives. Work on and provide solutions to a wide range of difficult problems relating to the quality aspects of design, validation, and manufacture of medical devices. The Senior Quality Engineer serves as owner and administrator of several aspects of the quality system, including but not limited to supplier management, customer feedback, process control, internal audits, change management, and design control. This quality and compliance professional will be responsible for assuring conformance to product serving as the site's lead ISO Representative.

ESSENTIAL JOB FUNCTIONS:

• Plans, implements, and directs quality program consistent with ISO13485 and AS9100 quality systems.
• Maintains and communicates quality objectives complementary to corporate policies and goals.
• Maintains a working knowledge of government and industry quality codes and standards.
• Assist in daily quality related requirements on the shop floor; such as in process and final inspection of parts and assemblies.
• Develops and directs internal audit program, customer audits, certification audits, and audits vendors/suppliers. Works to resolve issues and non-conformances found during audits.
• Leads investigations of customer complaints and ensures that corrective actions are implemented in a timely manner. Communicates with customer as required.
• Leads investigations of internal non conformance and ensures that root cause corrective actions are implemented in a timely manner and treated with the same importance as a customer complaint.
• Leads efforts to reduce quality issues including corrective action, preventive action and supplier quality concerns.
• Ensures purchases of materials meet customer requirements.
• Works with Manufacturing and Quality Engineers in the preparation of Quality Data Packets.
• Has active role on quality control team, leads team in document and data control.
• Promotes a positive and professional work environment.
• Leads and records company’s quality management review meetings.
• Serves as the liaison with 3rd party auditing and evaluation organizations.
• Monitors the approved supplier and supplier evaluation processes.
• Manages the process integrity/data collection processes and reporting to senior management.
• Oversees the customer satisfaction and evaluation process.
• Monitors laboratory processes and effectiveness.
• Utilize six-sigma quality tools, when appropriate, to define, measure, analyze, improve and control processes and outcomes.
• Responsible to maintain & support processes, procedures & K.P.I.’s owned by your position.

Requirements

ITAR REQUIREMENTS:

This position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person citizenship status.

QUALIFICATIONS:

• A bachelor’s degree in industrial management, quality management or related field.: three to five years related experience and/or training; or equivalent combination of education and experience.
• Demonstrate effective interpersonal and communication skills.
• Experience with ISO 13485 and/or AS9100 quality systems, quality planning and mechanical inspection
• Previous supervisory experience, quality function preferred.
• Demonstrate organizational and analytical skills.
• Ability to read and interpret documents, write reports and correspondence, and convey appropriate message to vendors, customers, and employees.
• Demonstrate the ability to manage risk and resolve conflict.
• Must be able to resolve complex manufacturing problems and troubleshoot manufacturing/production systems.
• Ability to apply your knowledge of mechanical engineering, machining, metrology instrumentation and experimental techniques in developing customer solutions.
• Experience and knowledge with ASME Y14.5.
• Experience with Streamics, Salesforce or other ERP system
• Experience with commercial 3D printing
• Knowledge of laser, CMM, and vision systems
• Experience with Supplier Certification and Supplier Quality Planning
• ASQ or similar professional certification
• Working knowledge of quality improvement tools, including Six Sigma

WORK ENVIRONMENT:

• The performance of this position will require exposure to the manufacturing areas where all areas require the use of personal protective equipment such as safety glasses, hearing protection, steel toe shoes, and other mandatory safety equipment.
• For the most part, ambient temperatures with typical plant lighting and manufacturing equipment are present throughout the facility.

PHYSICAL DEMANDS:

• Sit or stand as needed.
• Walking primarily on a level surface for periodic periods throughout the day.
• Reaching above shoulder height, below the waist, or lifting as required to reach documents or store materials throughout the workday.
• Proper lifting techniques required.
• Ability and comfortability to work in small confine spaces while following proper safety protocol.
• Ability to accomplish the physical requirements of the position with or without reasonable accommodation.

SAFETY AND POLICY PRACTICES:

Each employee must be knowledgeable of standard safety policies and procedures and adhere to the same while supporting the goals and objectives of the organization and recognizing the Company’s need to achieve its business objectives. Each employee is responsible for complying with company hazardous waste disposal procedures.

AFFIRMATIVE ACTION:

ADDMAN Engineering is proud to be an Equal Opportunity Employer of Minorities, Women, Protected Veterans, and Individuals with Disabilities. All terms and conditions of employment will be administered without regard to an individual’s sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by applicable law.

NOTE: This job description is intended to describe the general level of work being performed. This job description is not intended to be all-inclusive. The duties of this position may change from time to time, and the employee may perform other related duties to meet the ongoing needs of the organization. ADDMAN Engineering reserves the right to add, delete or modify these duties and responsibilities at its discretion. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. Employment is at-will, and nothing in this job description is intended to create or imply a contractual relationship or alter the at-will status of the employee.

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