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Director of Quality

Company Name: Hycor Biomedical
Location: Garden Grove, CA
Job Type: Full-time
Contact Name: Go to ADP webpage.

Job Description

• Manage and oversee the Quality System and day-to-day quality assurance operations.
• Develop budgets, plans, and priorities for quality assurance activities.
• Manage quality metrics: collect, maintain, trend, and analyze data.
• Ensure company-wide compliance with state, federal and international regulations and standards, as appropriate.
• Manage the document control, non-conforming material and CAPA systems.
• Participate in risk management and demonstrate a proficiency in ISO 14971.
• Make recommendations to the Management Representative and the executive team for correction of identified quality system, process, and product deficiencies.
• Review all V&V protocols and reports.
• Assist the Regulatory Department with pre- and post-market submissions – domestic and global submissions.
• Oversee calibration and maintenance of inspection and test equipment.
• Manage supplier control process and supplier audits.
• Manage internal audit process.
• Coordinate and conduct process validations.
• Review labeling and marketing materials for compliance with US and other country regulations as required.
• Prepare SOPs, WIs and specifications, as appropriate.
• Participate in product development and other interdisciplinary teams.
• Prepare and communicate performance reviews for all personnel.
• Monitor relevant standards and publications to ensure company stays in full compliance with “state of the art” practices and controls

Job Requirements

Bachelor of Science in chemistry, molecular biology or equivalent.
Detailed understanding of good laboratory procedures and practices.
Detailed understanding of the federal Quality System Regulation, ISO 9001, ISO 13485, and ISO 14971.
Understanding of process and product validation methods.


7+ years quality systems experience in the healthcare industry, of which at least 2-3 years should be in a leadership role, along with working and applied knowledge of the QSR (Quality System Regulation), ISO9001, ISO 13485, ISO 14971, and standard laboratory practices.

Experience working with a computer system and software pertaining to product manufacturing and inventory management.

Experience with total product lifecycle management software.

Knowledge of and experience with statistical quality/process control (ANSI sampling plans).

Knowledge of and experience with product and process validation methods.

Successful supervisory experience required.


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