Senior Quality Engineer

Position: Senior Quality Engineer

Experience:

Job Summary:

Senior Quality Engineer

Primary Responsibilities:

• Quality Management System (QMS):

• Maintain and update controlled documents within the QMS.
• Ensure QMS updates are compliant with ISO 13485, AS9100, NADCAP, and any future applicable standards.

• Root Cause & Corrective Action (RCCA):

• Participate in internal and external corrective action activities.
• Support leaders and teams in the use of RCCA tools (e.g., fishbone diagrams, 5-Whys, Pareto analysis, FMEA, process maps).
• Guide teams to identify true root causes and develop corrective actions that address systemic and human factors.
• Review completed corrective action plans for effectiveness and return inadequate plans to the owner for improvement.
• Ensure RCCA documentation is objective and complete.

• Advanced Product Quality Planning (APQP):

• Assist in the creation of Control Plans, FMEA, Process Maps, and Process Validation Plans.
• Develop and implement APQP processes and procedures.

• Supplier Quality Management:

• Collaborate with Supply Chain to ensure Purchase Orders include appropriate quality and regulatory requirements.
• Review supplier documents (e.g., Certificates of Conformance, FAI packages) for compliance with PO, drawings, and applicable standards.
• Create supplier PPAP/FAI/FMEA expectations based on customer drawings and specifications.
• Verify supplier compliance with regulatory standards such as REACh, RoHS, Conflict Minerals, and UL.

• Inspection & Training Documentation:

• Prepare inspection checklists and training materials based on customer specifications and engineering drawings.
• Assist in developing Final Inspection and In-Process Inspection Forms for finished goods.
• Support the creation of training materials to reduce or eliminate repeat defects.

Knowledge & Skill Requirements:

• Strong verbal and written communication skills.
• Ability to read and interpret engineering drawings and assembly prints.
• Proficient in working both independently and within cross-functional teams.
• Familiarity with quality tools such as FMEA, Control Plans, Process Mapping, and RCCA methodologies.
• Knowledge of ISO 13485, AS9100, NADCAP, and related quality and regulatory standards.
• Experience with supplier quality management and documentation review.

Education: