This position will support new product introductions, ensuring adherence to quality system requirements for medical device manufacturing in accordance with regulatory standards.

Responsibilities:

• Drive quality-related activities for new product introductions.
• Conduct CAPAs (Corrective and Preventive Actions) and NCRs (Non-Conformance Reports).
• Perform validations, including IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification).
• Conduct capability studies (Cpk) and FMEA (Failure Mode and Effects Analysis).
• Analyze data and trends in complaints, supplier quality, nonconforming material, and training effectiveness.
• Write documentation for process validations.
• Work closely with manufacturing engineers and the quality department.

Qualifications:

• Bachelor's Degree in Engineering.
• 3 years of experience as a quality engineer in a highly regulated industry (aerospace and automotive experience considered).
• Understanding of ISO 13485, with knowledge of AS9100 or IATF 16949 standards preferred.
• Familiarity with FDA CFR820 is a plus.
• Experience in capability studies (Cpk) and leading CAPA activities.
• Experience in writing NCRs and performing validations.
• Proficiency in FMEA and new product introductions.
• Experience with industrial machinery processes (EDM, CNC, Finishing, etc.).
• Computer literacy, including experience with Minitab and Excel for data collection and organization.