Job Title: Quality Engineer Medical Devices

Location: Multiple location in USA

Job Summary:
We are seeking a skilled and detail-oriented Quality Engineer to join our team in the medical device industry. The successful candidate will play a critical role in ensuring compliance with quality standards and regulations while driving continuous improvement initiatives. This role involves working closely with cross-functional teams to support CAPA, NCR, and process validation activities.

Key Responsibilities:

• Lead and manage Corrective and Preventive Actions (CAPA) to address product or process deficiencies and ensure timely closure.
• Investigate and resolve Non-Conformance Reports (NCR), including root cause analysis and implementation of corrective actions.
• Develop, execute, and document process validations (IQ, OQ, PQ) to support new product introductions and manufacturing process improvements.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
• Collaborate with manufacturing, design, and regulatory teams to identify quality risks and implement mitigation strategies.
• Conduct internal audits and participate in external audits to maintain compliance and certification standards.
• Monitor and analyze quality metrics, driving initiatives for continuous improvement.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 3+ years of experience in quality engineering within the medical device industry.
• Strong knowledge of CAPA, NCR, and process validation methodologies.
• Familiarity with regulatory requirements (FDA, ISO 13485).
• Excellent problem-solving and analytical skills with experience in root cause analysis tools.
• Proficiency in quality tools such as FMEA, SPC, and statistical analysis software.
• Strong communication and teamwork skills.

Preferred Qualifications:

• ASQ Certified Quality Engineer (CQE) or equivalent certification.
• Experience with Class II or Class III medical devices.