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Senior Quality Assurance Engineer
at Nihon Kohden
Senior Quality Assurance Engineer
|Department:||Quality Assurance & RA OM|
|Location:||Santa Ana, CA|
The Senior, Quality Assurance Engineer works under the instruction of the Head of Quality. This position helps to support the manufacturing of medical devices from a quality perspective.
Duties and responsibilities
- Develop Quality System Processes in compliance with US-FDA, MDD/MDR, ISO 13485 and other applicable country specific medical device regulations.
- Develop Quality Plans for implementation of new processes or improvements to existing processes
- Conduct internal quality audits to ensure compliance to Quality System and regulatory requirements.
- Facilitate receiving inspection and first article inspection activities. Help establish receiving inspection requirements for materials and any needed inspection/testing procedures.
- Facilitate calibration activities by monitoring calibration logs to ensure on-time calibration, working with inspectors, development of calibration requirements and test methods.
- Control of suppliers including supplier approval, supplier audits, supplier monitoring and supplier corrective action.
- Facilitate material review board meetings. Establish and maintain non-conforming material system.
- Daily line support activities in manufacturing.
- Support manufacturing in process validation activities.
- Establish and maintain corrective/preventive action system. Work with responsible engineering personnel to perform root cause analysis, develop and implement action plans, and follow-up on implementation and effectiveness of actions taken.
- Collection and trending of key quality indicators for management review.
- Support transfer of products from development to manufacturing.
- Perform other related functions as required by quality management.
- Bachelor’s degree in a technical field as Engineering or Biological Science and a minimum of eight-years experiences in the field of medical device manufacturing quality assurance, prior experience with medical electronics preferred;
- Ability to work with minimal direct leadership in a fast-paced environment;
- Ability to read and interpret engineering drawings, schematics and specifications;
- Self-motivated, detail oriented, and well-organized with good communication skills, both written and oral;
- Strong analytical problem-solving ability required;
- Proficient computer skills which include the use of Microsoft WORD, EXCEL, and POWERPOINT. Prior use of an electronic document control system, ERP system and FDA eMDR reporting.
- ASQ Certifications such as Manager of Quality/Organizational Excellence, Quality Engineer, Quality Auditor, Supplier Quality Professional, etc.
- Certified ISO 13458 / MDD lead auditor.
- A Senior, Quality Assurance Engineer usually works in an office environment which includes laboratory and manufacturing areas. Occasional domestic travel may be required.
- A Senior, Quality Assurance Engineer works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.
Must be able to type using the keyboard of a computer. Must be able to talk, listen and speak clearly on the telephone. Must be able to lift and carry up to 50 lbs.
EEO Policy Statement
It is the policy of Nihon Kohden America not to discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran. It is also the policy of Nihon Kohden America to take affirmative action to employ and to advance in employment, all persons regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or protected veteran status, and to base all employment decisions only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment.
Employees and applicants of Nihon Kohden America will not be subject to harassment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability, or because he or she is a protected veteran. Additionally, retaliation, including intimidation, threats, or coercion, because an employee or applicant has objected to discrimination, engaged or may engage in filing a complaint, assisted in a review, investigation, or hearing or have otherwise sought to obtain their legal rights under any Federal, State, or local EEO law is prohibited.
As CFO of Nihon Kohden America, I am committed to the principles of Affirmative Action and Equal Employment Opportunity. In order to ensure dissemination and implementation of Equal Employment Opportunity and affirmative action throughout all levels of the company, I have selected Melanie Nguyen, Human Resources Representative, as the Equal Employment Opportunity (EEO) Manager for Nihon Kohden America. One of the EEO Manager’s duties will be to establish and maintain internal audit and reporting systems to allow for effective measurement of Nihon Kohden America’s programs.
In furtherance of its policy regarding Affirmative Action and Equal Employment Opportunity, Nihon Kohden America has developed a written Affirmative Action Program which sets forth the policies, practices and procedures that Nihon Kohden America is committed to in order to ensure that its policy of nondiscrimination and affirmative action is accomplished. This Affirmative Action Program is available in the Human Resources office for inspection by any employee or applicant for employment upon request, during normal business hours. Interested persons should contact Melanie Nguyen at 949-268-7725 for assistance.
We request the support of all employees in accomplishing Equal Employment Opportunity.