Senior Quality Engineer Job in San Diego 92123, California Us
Senior Quality Engineer
ResMed is a global leader in the development, manufacturing and marketing of innovative medical products for the treatment and management of respiratory disorders, with a focus on sleep-disordered breathing. Our employees and distributors are located in more than 60 countries. At ResMed we are committed to providing an environment that fosters broad communication, focused work, and strong relationships. Innovative individuals and diverse teams have strengthened ResMed and will continue to spark growth. ResMed looks for people who want to be challenged and to be rewarded for meeting those challenges.
Employees at ResMed are the most important asset, so we offer a benefits package that promotes physical, emotional, and financial health for employees and their families. Our insurance plans and support programs cover the full spectrum of personal needs: medical, chiropractic/acupuncture, dental, vision, long-term care, life/ADD, LTD/STD, EAP, 401(k), compensated time off, tuition reimbursement, yoga classes, and massage.
SUMMARY
A Senior Quality Engineer shall support the company goal of maintaining a quality system that is compliant with quality standards and regulatory requirements. These activities shall support the goal of continuous improvement to achieve improved complaints handling, regulatory compliance, product quality, and internal quality and efficiency.
Senior Quality Engineer shall perform activities similar to a Quality Engineer but with increased proficiency and with greater responsibility and authority for the establishment, implementation, maintenance, and improvement of select Quality procedures and processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Performs to individual goals established during performance reviews and/or goal setting meetings.
- Follows, maintains, and improves established quality systems and procedures.
- Performs activities essential to satisfying the goals as defined in the summary above. These activities may include but are not limited to the following:
- Supporting the non-conforming material system including: ensuring compliance to procedures; performing root cause analyses; performing trend analyses; developing and implementing corrective actions; improving procedural efficiencies.
- Performing complaint investigations including: analyzing returned products; updating records as required; and generating escalation and MDR reports as required.
- Supporting global regulatory systems and implement regulatory requirements.
- Performing product, data, and trend analyses to support organizational needs and continuous improvement activities.
- Coordinating with appropriate individuals within the organization and other ResMed entities.
QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
- Bachelor degree and five years related experience; or equivalent combination of education and experience; or as deemed appropriate by Management.
- Must be knowledgeable with ISO 13485:2003 and CFR 21.
- ASQ certified CQE or CQMOE is a plus.
- Job experience should be in an FDA regulated environment and preferably associated with medical devices.
LANGUAGE SKILLS
- Excellent computer and communication skills.
- Ability to read, interpret, and implement regulatory documents, procedures, and reports.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedures.
- Ability to speak effectively to supervisor, team members, and employees.
- Ability to effectively write reports, work instructions, and procedures.
MATHEMATICAL SKILLS
- Excellent analytical and problem solving skills.
- Ability to understand and utilize probability and statistical quality tools.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals.
REASONING ABILITY
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Normally follows established procedures on daily work, requires instructions only on new assignments. Ability to evaluate, improve, or create procedures and work instructions.
OTHER SKILLS AND ABILITIES
- Ability to read, understand, and create procedures, work instructions, material lists and bills of material.
- Ability to perform basic computer operations.
- Ability to function in a team environment.
- Ability to recognize basic component nonconformance.
- Ability to use common hand tools.
- Mechanical aptitude.
- Hand-eye coordination.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel objects, tools or controls and talk and hear. The employee frequently is required to stand and sit and reach with hands and arms. The employee is occasionally required to walk, stoop, kneel, crouch and smell.
The employee must occasionally lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include peripheral vision, depth perception, and the ability to adjust focus.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The typical work environment will be an office setting. Occasionally work will be performed in a warehouse, lab, or manufacturing environment.
While performing the duties of the job, the employee is occasionally exposed to airborne particles.
The noise level in the work environment is usually moderate.
We are sorry, but at this time we cannot offer relocation assistance for this position.
ResMed is an equal opportunity employer and supports workforce diversity.
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