Quality Engineer II

Roles and Responsibilities

• Support the maintenance and drive improvement of the internal quality management system in accordance with ISO 17021, ISO 17025, 14065 and other regulatory/accreditation requirements.
• Manage assigned accreditation audit program and conduct internal audits as scheduled.
• Own and analyze nonconformities and customer complaints for assigned accreditation.  Initiate needed actions, manage the corporate procedure and close CAPAs and complaints on time.
• Perform risk analysis for accreditation in your ownership, provide mitigation and escalate appropriately.
• Write necessary controlled documents such as but not limited to quality procedures, work instructions and forms as required.
• Perform data analytics to drive improvement project ideas
• Prepares reports by collecting, analyzing, and summarizing data, making recommendations for process improvements.
• Provide engineering support to operations ensuring consistent application of quality techniques
• Mentor and coach Quality team members and stakeholders on advanced statistical tools and analysis.
• Collaborate effectively with technical and non-technical stakeholders to analyze any issues, provide root cause analysis and resolution.
• Influence and communicate effectively with stakeholders to ensure highest levels of quality for the product/platform in your ownership.
• Complete or own other tasks or special areas of focus as may be assigned by Manager, in support of quality management and certification body activities, including, but not limited to reviewing of audit report packages, internal training, supplier audits, etc.
• This role may require up to 35% travel.

Education

• Bachelor's Degree (B.A.) in Technical or Business area (or equivalent experience)
• 5+ years experience in maintaining / improving Quality Management Systems (QMS) or direct lab experience as a test engineer or similar.
• Excellent knowledge of one or more accreditations such as 17021, 17026, 17065, MDSAP, 13485.
• Green belt or equivalent lean knowledge preferred.

Skills    

• Accurate, clear, and timely communicate of information, upward and lateral, including verbal, written and listening skills;
• Ability to plan and organize giving attention to detail and follow-through;
• Reliable judgment that is consistent, adaptable to unusual situations, realistic, common-sense approach to job and problems;
• Motivation, initiative, commitment, to self improvement;
• Willingness to consider other’s ideas and to work with others.

Additional information

Equal Opportunity Employer – Disability and Veteran

TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.

For more information on applicable equal employment regulations, please refer to the following: Labor Law 2024