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Quality Manager (In-vitro Diagnostics)

Lab Support, A Division Of On Assignment

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Location: Orange, CA Posted Date: 5/2/2013 Position Type: Full time Job Code: CM 0003 Required Education: High school or equivalent

Description

Growing In-vitro Diagnostic Medical Device Company is seeking a Quality Manager to join their team.

The ideal candidate will have over 5 years of Quality Assurance & Quality Systems Managerial experience in the IVD industry. Must have knowledge and prior application experience with QSR, ISO 9001, and ISO 13485.  ASQ CQA or CQLA certification is highly desired. The company offers competitive pay, full benefits, a cohesive work atmosphere, alternative work schedule, and a dynamic work environment.

Duties and Responsibilities
•   Manage and oversee component release for packaging based on analytical results.
•   Supervise reagent raw material release into inventory.
•   Ensure company-wide compliance with state, federal and international regulations and standards, as appropriate.
•   Manage and oversee:
o   The data collection and analysis system
o   The document control system
o   The administration of the corrective and preventive action system
o   The raw materials testing function
•   Communicate, both orally and in writing, with customers and suppliers, as appropriate.
•   Coordinate the regular Issues Investigation meeting and follow up on action
•   Participate in the company Management Review as appropriate.
•   Supervise all aspects of the quality testing function for all diagnostic and control products.
•   Coordinate with other departments in examining operational or functional problems that affect product quality.
•   Assist with preparation of work instructions and specifications, as appropriate.
•   Resolve all non-conformances.
•   Contribute to the testing program for customer complaints.
•   Participate in the development of new products, as appropriate.
•   Review Engineering Change Documents, as appropriate.
•   Ensure department equipment is properly maintained and calibrated.
•   Prepare and communicate performance reviews for all laboratory personnel.
•   Monitor Quality department labor and cost variances.
•   Prepare the annual budget for the Quality Laboratory cost center.
•   Assist in conducting failure investigations, corrective action and preventive action, as appropriate.
•   Ensure department personnel are adequately trained in the performance of their jobs.

Requirements

•   B.S. in Chemistry, Biology, Biotechnology, Molecular Biology or related
•   Has 5 – 10 years’ quality systems experience (QA, QC, Compliance)
•   Has 2+ years supervisory Managerial/Leadership experience
•   Has experience in the medical device manufacturing field
•   Has working and applied knowledge of the FDA QSR (Quality System Regulation), ISO9001, ISO13485 and standard laboratory practices
•   Has experience with an internal audit system Quality System Audits
•   Understands the importance of focus on safety, compliance, operational excellence and financial performance.
•   Demonstrates professional leadership with the proven ability to build business relationships
•   Has proven influence, leadership and facilitation skills.
•   Proactively identifies issues and seeks resolution within the team.
•   Demonstrates organizational skills, and is capable of managing multiple tasks.
•   Has the ability to pay attention to details and accuracy while being flexible and able to adapt to changing priorities
•   Thrives in a fast-paced environment
•   Is able to manage time with respect to priorities
•   Can communicate effectively across all levels of the organization.
•   Has direct experience interfacing with the FDA and ISO auditors
•   Has experience in in vitro diagnostics medical device
•   Has experience with Canadian medical device regulations and European in vitro diagnostic directives
•   Has a Certification issued by the American Society for Quality
•   Is a Certified Quality Auditor or Certified Quality Lead Auditor
•   Has direct experience with validations (process, equipment, software)
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