Quality Assurance Manager

5 days ago

San Diego, California, United States Ignite Human Capital Full time

Job Summary:

We are seeking a highly skilled Quality Assurance Manager to join our team at Ignite Human Capital. As a key member of our organization, you will be responsible for ensuring the adequacy and compliance of our Quality Management System (QMS) with all relevant regulatory standards.

Key Responsibilities:

  • Management Representative: Serve as the Management Representative, ensuring the QMS is compliant with ISO 13485 standards and regulatory requirements.
  • Quality Staff Development: Mentor and develop the Quality Staff, fostering a culture aligned with our company's core values.
  • QMS Activities: Oversee all QMS activities, including training, customer feedback management, deviations, corrective actions, supplier quality, and change control.
  • Budget Management: Exercise judicious budget management in Quality operations.
  • Quality Assurance Expertise: Provide expertise in quality assurance judgment and assessments.
  • QMS Enhancement: Continuously enhance the QMS to adapt to evolving business needs.
  • Company Quality Objectives: Lead the Company Quality Objectives and facilitate their achievement.
  • Audit and Compliance: Conduct audits from regulatory agencies and ensure compliance with ISO 14971 for risk management.
  • Quality Actions: Drive quality actions based on data analysis from internal manufacturing, customer feedback, and device performance.
  • Audit Activities: Lead internal, external, and supplier audit activities.
  • Quality Plans: Manage quality plans and oversee the review and approval of components and finished products.

Requirements:

  • Education: Bachelor's degree in life science or related field, engineering, or scientific discipline preferred.
  • Experience: Minimum of 7 years of quality experience in medical device, IVD, or biotech industries.
  • Leadership Experience: At least 3 years in a leadership and direct line management role.
  • QMS Governance: Demonstrated competency in QMS governance and standards.
  • Business Environment: Ability to thrive in a small to medium-sized early-stage commercial business environment.

Key QMS Governance and Standards:

  • Regulatory Expertise: Expertise in relevant regulations including 21 CFR Part 820, ISO 13485, MDD, MDR, MDSAP, ISO 14971, cGDP, GMP, and 5S principles.

Physical Demands and Work Environment:

  • Communication and Lifting: Regular communication and occasional lifting of up to 25 pounds may be required.
  • Work Environment: Work primarily in a general office environment with exposure to PCs and networks.
  • Noise Level: Moderate noise level in the work environment.
  • Travel: Travel may be necessary.

Compensation:

Between $115-140K base, plus bonus - with title and compensation level depending on experience.

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