Quality Engineer

Yanfeng•Novi, MI

24d•Onsite

About The Position

Main Responsibilities 1. Quality Manual development and maintenance. 2. Conduct Training of internal staff as it relates to the quality manual and quality system. Facilitate certification of employees as needed. 3. Initiate and secure audits (compliance, process, methods, test) in an efficient manner, delegate authority to auditors and follow up corrective action if needed. 4. Lead internal and external audits (ISO 17025; IATF 16949, 5S), report deficiencies and ensure timely closure of corrective actions. 5. Review and monitor outside vendors. 6. Maintain and review non-conformance and corrective action reports. Present findings to the Validation Team. 7. Initiate and participate in Management Review of the Quality System 8. Maintain and review Customer Complaints, Risks to Impartiality, and PM records. 9. Maintain and update the training system, including the training matrix 10. Administer and support the test quality tracking, instrument calibration processes, and equipment tracking in LIMS system. 11. Maintain internal and global KPI’s for Laboratory Quality. 12. Review and maintain validation department documents. 13. Review and approve reports outsource reports in VOS. 14. Maintain warehouse shipping and receiving log. 13 Perform other duties as assigned by Supervisor. Specific Requirements: Bachelor's degree in Quality, Engineering, or Science related field with at least 3-5 years of related work experience as Quality Engineer or 10+ years of work experience in Quality (ISO 17025 environment preferred). Experience with ISO/QS/TS Quality Systems is required. Lead Auditor certification for ISO/IEC 17025:2017, highly desired. Experience in implementing processes to meet ISO/IEC 17025:2017. 3-5+ years’ experience working in an accredited testing environment is a plus. Qualifications (General/EHS/Quality) Test Lab experience (equipment, methods, instruments) Knowledge and experience with ISO 17025 and the accreditation/auditing process Proficient in use of a computer and common office software (i.e. Word, Excel, and PowerPoint). Strong interpersonal and communication skills, including ability to work in a self-directed environment. Excellent problem-solving skills, including experience preparing problem solving documents such as 8D or A3. Post –test data interpretation and/or analysis experience Physical Requirements Ability to work in a lab environment with equipment, fixtures, controllers. Language Skills Required: English - Proficient Regional Requirement: The position is located at a corporate office. Travel to customer, Company manufacturing sites, and supplier sites will be involved. The position may require work with potentially hazardous products in a controlled, safe environment. Common Requirements: International Operating System (IOS): Understand, apply and meet all function-related IOS requirements. Environmental, Health & Safety (EHS): Understand, apply and meet all function-related EHS requirements. Usage of a LIMS system (VOS) to track equipment, reports and other documentation. Compliance: Understand, apply and meet all function-related compliance requirements Information Security: Understand, apply and meet all function-related IT / Information Security and confidentiality of YFAI information requirements. Support continuous improvement projects as required.

Requirements

Bachelor's degree in Quality, Engineering, or Science related field with at least 3-5 years of related work experience as Quality Engineer or 10+ years of work experience in Quality (ISO 17025 environment preferred).
Experience with ISO/QS/TS Quality Systems is required.
English - Proficient
Understand, apply and meet all function-related IOS requirements.
Understand, apply and meet all function-related EHS requirements.
Usage of a LIMS system (VOS) to track equipment, reports and other documentation.
Understand, apply and meet all function-related compliance requirements
Understand, apply and meet all function-related IT / Information Security and confidentiality of YFAI information requirements.
Support continuous improvement projects as required.

Nice To Haves

Lead Auditor certification for ISO/IEC 17025:2017, highly desired.
Experience in implementing processes to meet ISO/IEC 17025:2017.
3-5+ years’ experience working in an accredited testing environment is a plus.
Test Lab experience (equipment, methods, instruments)
Knowledge and experience with ISO 17025 and the accreditation/auditing process
Proficient in use of a computer and common office software (i.e. Word, Excel, and PowerPoint).
Strong interpersonal and communication skills, including ability to work in a self-directed environment.
Excellent problem-solving skills, including experience preparing problem solving documents such as 8D or A3.
Post –test data interpretation and/or analysis experience

Responsibilities

Quality Manual development and maintenance.
Conduct Training of internal staff as it relates to the quality manual and quality system.
Facilitate certification of employees as needed.
Initiate and secure audits (compliance, process, methods, test) in an efficient manner, delegate authority to auditors and follow up corrective action if needed.
Lead internal and external audits (ISO 17025; IATF 16949, 5S), report deficiencies and ensure timely closure of corrective actions.
Review and monitor outside vendors.
Maintain and review non-conformance and corrective action reports.
Present findings to the Validation Team.
Initiate and participate in Management Review of the Quality System
Maintain and review Customer Complaints, Risks to Impartiality, and PM records.
Maintain and update the training system, including the training matrix
Administer and support the test quality tracking, instrument calibration processes, and equipment tracking in LIMS system.
Maintain internal and global KPI’s for Laboratory Quality.
Review and maintain validation department documents.
Review and approve reports outsource reports in VOS.
Maintain warehouse shipping and receiving log.
Perform other duties as assigned by Supervisor.