Quality Engineer

Pay: $36-$45/hr

Essential Duties and Responsibilities:

• Conduct thorough investigations and root cause analyses to address non-conformances, deviations, and customer complaints, utilizing tools such as CAPA methodologies

• Generate and manage CAPAs, ensuring timely resolution and implementation of corrective actions to prevent recurrence

• Author, review, and close Non-Conformance Reports (NCRs), documenting findings, corrective actions, and follow-up activities

• Collaborate with cross-functional teams to update and revise quality procedures, work instructions, and SOPs to enhance efficiency and compliance

• Perform quality inspections and reviews of finished goods, ensuring adherence to specifications, standards, and customer requirements

• Oversee equipment calibration activities, ensuring the accuracy and reliability of measurement and test equipment used in manufacturing processes

• Able to conduct incoming QC inspections to verify the compliance of raw materials and components with established specifications

• Provide guidance and support to manufacturing personnel on quality-related matters, including process improvements, compliance issues, and quality control techniques

• Conduct supplier audits and assessments, evaluating supplier performance and adherence to quality standards, with a focus on continuous improvement and risk mitigation

• Participate in Cleanroom activities and ensure compliance with cleanliness and contamination control requirements per ISO 14644

• Drive continuous improvement initiatives through data analysis, trend identification, and implementation of best practices to enhance product quality and operational efficiency

Minimum Qualifications and Experience:

• Bachelor's degree in Engineering, Quality Assurance, or related field; advanced degree preferred

• Minimum of 5 years of experience in quality engineering or related roles within the medical device industry

• Proficient understanding of ISO 9001, ISO 13485, and CFR 820 standards and regulatory requirements

• Strong analytical and problem-solving skills, with experience in conducting investigations and root cause analyses

• Demonstrated experience in completing CAPAs, NCRs, and updating quality procedures and documentation

• Familiarity with Cleanroom operations and contamination control practices preferred

• Experience in Supplier Quality Management, including supplier audits, SCARs, and assessments, preferred

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across cross-functional teams

• Detail-oriented mindset with a commitment to quality excellence and continuous improvement

• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) credentials preferred