Quality Manager

Quality Manager

Industry: Biotech

Type: Direct

Location: Fremont, CA

Pay Rate: 120-150k

A contract manufacturing company that specialize in medical device and life sciences is seeking a Quality Manager to join their team in Fremont, CA.

Summary: 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.

Additional Info:

For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.

Richmar is an Equal Opportunity Employer.