Quality Engineer

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:

• 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.

Qualifications:

• 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.

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-time

Pay: $90,300.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Required)

Ability to Relocate:

• Fremont, CA: Relocate before starting work (Required)

Work Location: In person