Sr Complaints Quality Engineer
30031 Ahern Ave Union City, CA 94587
Sr Complaints Quality Engineer
The Sr Complaints Quality Engineer is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. The position manages quality assurance programs and processes to ensure the quality of product conforms to the established procedures and applicable regulatory requirements. The position utilizes technical expertise on the FDA’ s QSR, ISO 13485, ISO 14971, MDD for Class I and Class II medical devices for capital equipment and their accessories.
The Sr. Quality Assurance Engineer position supports in achieving established goals and objectives and follows the Corporate Vision, Mission & Values Statements, to maintain the services and quality levels.
ESSENTIAL JOB FUNCTIONS:
Provide QA Engineering input and guidance during manufacturing, production and design activities in support of new product introductions and modifications to existing products. The support includes but is not limited to the review and approval of validation documentation, test reports, and procedures through ERCN and/or ECN processes.
Conduct Internal Audits to ensure compliance to the established procedures and applicable regulatory requirements. Manage and contribute to the closure of internal and external audit findings.
Manage processing of Complaints and CAPAs in a paper based quality system. Be the SME and conduct review board meetings to review status against the established metrics.
Track and trend Complaints, CAPAs, NCRs, QSVs and prepare presentations for Quarterly Review meetings.
Co-Chair Material Review Board (MRB) meetings for review of non-conforming materials. Using sound judgement, and impact analysis, negotiate quality decisions.
Utilize standard statistical analysis techniques to determine product acceptance: evaluate process capabilities; and develop statistically sound tolerance limits based on product specifications, recommend sampling plans, inspection methods, etc.
Provide assistance and/or perform inspection, and electrical safety testing.
Responsible for a professional work area to include cleanliness, organization, and overall QA department appearance.
To be willing to share knowledge and instruct other members of the department and the company, by passing along skills and information to assist then in their development.
To help create an ongoing effort through personal action and by contributing ideas to support both the department and Company’ s ongoing improvement efforts.
To understand the business objectives and the relationship between the department and those objectives.
To understand, follow and support internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations, ISO 13485 and applicable International Standards).
MINIMUM QUALIFICATIONS - Unless noted, the qualifications below are the knowledge, skills, and abilities required to do this job. Reasonable accomodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE: Bachelor’ s degree in Science, or related field and 5 to 7 years of related experience in mechanical or electro machinal medical device manufacturing.
KNOWLEDGE, SKILLS AND ABILITIES:
Experience with mechanical and electro-mechanical medical device manufacturing.
Previous experience with managing quality systems: CAPA, Complaints processing, NCR, Deviations.
Thorough knowledge on ISO standards, FDA’ s QSR, MDD and other regulations as applicable to the product.
ASQ Certification for CQE, CQA. Auditor certification for ISO 13485 is desirable.
Demonstrated knowledge of engineering applications, CAD and Solid Modeling software
General understanding of Geometric Dimensioning and Tolerance (GD&T) skills
Familiarity with “ Lean” manufacturing principles is preferred
Ability to work independently and collaboratively with small and cross functional teams.
Excellent computer skills including operating Windows based personal computers, various office equipment and machines, and telephone system. Ability to efficiently and effectively use Microsoft products such as Outlook, Word, Excel, Project, Visio and PowerPoint to analyze data, produce trend charts and presentation.
Ability to clearly express oneself verbally in the English language (additional languages also preferred) using good grammar, vocabulary, eye contact, and friendly voice inflection with all employees. Ability to communicate effectively with employees and other business contacts in a courteous and professional manner.
Excellent customer focus with a high sense of urgency to create positive experiences, and if applicable, resolutions. Ability to provide excellent interpersonal and communication skills.
Ability to function calmly in a fast paced environment managing multiple priorities simultaneously. To be able to positively manage situations of a dynamic nature; to be able to modify plans, actions, and decisions in light of changing situations and circumstances while still meeting, or proposing modified, deadlines.
Ability to clearly and effectively express oneself through written means, to properly use such technical factors as grammar, punctuation, vocabulary, and correct spelling. To be able to prepare business letters, memorandums, and reports. Excellent verbal and written communication skills, strong presentation, project and organizational skills.
Ability to perform basic statistical analysis, calculating C&R, create and reconcile reports, demonstrate strong analytical skills, and attention to detail.
To respond sensitively to the needs and feelings of others regardless of position; to accept interpersonal differences, to maintain rapport, and to interact effectively with all levels of employees within the organization.
To be able to demonstrate an understanding, and the regular use of a time management process, which systematically structures one’ s own work to provide for effective task performance and to plan and prioritize items to meet future demands.
Ability to establish and accomplish goals independently and to function as a positive and productive team member.
The physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Duties are performed while sitting at a desk for long periods of time. Required duties include operating a computer, reading, writing and using a telephone. Walking or standing within the office and production areas is required. Bending, stooping and kneeling occasionally may be required. The employee may be required to lift 25 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Job duties are performed in an office and production environment utilizing standard office equipment such as a computer, photocopier, and telephone. The noise level in the work environment is usually low to moderate.
Within the Assembly/Production floor the employee may be exposed to sharp objects, small tools, hot objects, adhesives, UV light, various testing equipment, isopropyl alcohol, soldering equipment, hi-pot testers and other electrical test equipment, etc. The noise level in the work environment is usually moderate to high.