Qureos Mentor

Evolve Manufacturing Technologies Inc

Company Overview: Evolve is a leading contract manufacturer in the medical device industry, specializing in the production of cutting-edge medical devices. We are committed to delivering high-quality products that meet the stringent standards of regulatory authorities and exceed the expectations of our clients. As we continue to grow, we are seeking a talented and experienced Quality Engineer to join our dynamic team.Job Description:As a Quality Engineer at Evolve, you will play a pivotal role in ensuring the quality and compliance of our manufacturing processes and products. You will work closely with cross-functional teams to implement and maintain quality systems, drive continuous improvement initiatives, and assure product quality. The ideal candidate will have a strong background in quality management within the medical device industry, with expertise in ISO 9001, ISO 13485, and CFR 820 standards.Key Responsibilities:<ul><li>Conduct thorough investigations and root cause analyses to address non-conformances, deviations, and customer complaints, utilizing tools such as CAPA methodologies.</li><li>Generate and manage CAPAs, ensuring timely resolution and implementation of corrective actions to prevent recurrence.</li><li>Author, review, and close Non-Conformance Reports (NCRs), documenting findings, corrective actions, and follow-up activities.</li><li>Collaborate with cross-functional teams to update and revise quality procedures, work instructions, and SOPs to enhance efficiency and compliance.</li><li>Perform quality inspections and reviews of finished goods, ensuring adherence to specifications, standards, and customer requirements.</li><li>Oversee equipment calibration activities, ensuring the accuracy and reliability of measurement and test equipment used in manufacturing processes.</li><li>Able to conduct incoming QC inspections to verify the compliance of raw materials and components with established specifications.</li><li>Provide guidance and support to manufacturing personnel on quality-related matters, including process improvements, compliance issues, and quality control techniques.</li><li>Conduct supplier audits and assessments, evaluating supplier performance and adherence to quality standards, with a focus on continuous improvement and risk mitigation.</li><li>Participate in Cleanroom activities and ensure compliance with cleanliness and contamination control requirements per ISO 14644.</li><li>Drive continuous improvement initiatives through data analysis, trend identification, and implementation of best practices to enhance product quality and operational efficiency.</li></ul>Qualifications:<ul><li>Bachelor's degree in Engineering, Quality Assurance, or related field; advanced degree preferred.</li><li>Minimum of 5 years of experience in quality engineering or related roles within the medical device industry.</li><li>Proficient understanding of ISO 9001, ISO 13485, and CFR 820 standards and regulatory requirements.</li><li>Strong analytical and problem-solving skills, with experience in conducting investigations and root cause analyses.</li><li>Demonstrated experience in completing CAPAs, NCRs, and updating quality procedures and documentation.</li><li>Familiarity with Cleanroom operations and contamination control practices preferred.</li><li>Experience in Supplier Quality Management, including supplier audits, SCARs, and assessments, preferred.</li><li>Excellent communication and interpersonal skills, with the ability to collaborate effectively across cross-functional teams.</li><li>Detail-oriented mindset with a commitment to quality excellence and continuous improvement.</li><li>Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) credentials preferred.</li></ul>Join our team as a Quality Engineer and contribute to our commitment to delivering high-quality products. We offer competitive compensation packages, opportunities for professional growth, and a collaborative work environment. Apply today to take the next step in your career!Job Type: Full-timePay: $90,300.00 - $100,000.00 per yearBenefits:<ul><li>401(k)</li><li>Dental insurance</li><li>Flexible spending account</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Education:<ul><li>Bachelor's (Required)</li></ul>Ability to Relocate:<ul><li>Fremont, CA: Relocate before starting work (Required)</li></ul>Work Location: In person

Quality Engineer

Join Evolve Manufacturing Technologies Inc and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Evolve Manufacturing Technologies Inc

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Quality Engineer