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 quality procedures, work instructions, and forms as required.
* Perform data analytics to drive improvement project ideas.
* Prepare reports by collecting, analyzing, and summarizing data, and make 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 issues, provide root cause analysis, and implement resolutions.
* Influence and communicate effectively with stakeholders to ensure the highest levels of quality for the product/platform in your ownership.
* Complete or own other tasks or special areas of focus as assigned by the Manager, supporting quality management and certification activities, including reviewing audit report packages, internal training, and supplier audits.
* This role may require up to 35% travel.
Education
* Bachelor's Degree (B.A.) in a Technical or Business field (or equivalent experience).
* 5+ years of experience in maintaining or improving Quality Management Systems (QMS) or direct lab experience as a test engineer or similar.
* Excellent knowledge of accreditations such as 17021, 17026, 17065, MDSAP, 13485.
* Green belt or equivalent lean knowledge.
Skills
* Effective communication skills, including verbal, written, and listening skills.
* Ability to plan and organize with attention to detail and follow-through.
* Reliable judgment, adaptability, and a common-sense approach to problems.
* Motivation, initiative, and commitment to self-improvement.
* Willingness to consider others' ideas and collaborate effectively.
Additional Information
Equal Opportunity Employer – and Veteran
TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants without regard to race, creed, ancestry, marital status, genetics, gender, expression, physical or mental disability, veteran status, and in accordance with applicable laws and regulations. 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.
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