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Medical Device, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
Job Title: Director of Quality
Job Location: Cleveland, Ohio 44114
Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer, infectious diseases, and certain neurological diseases, such as Alzheimer’s disease.
We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee’s well-being and happiness as the primary reason for our success. Are you interested in building your career with a Team of industry professionals with inspiring work and a challenging career while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics. Find out more about us at www.ClevelandDx.com.
Cleveland Diagnostics offers an Extremely robust benefits package which includes:
100% Employer paid employee medical coverage effective on your date of hire and 50% employer paid spouse/dependent coverage.
100% Employer paid Medical, Dental, Vision, Group Term Life, Short term Disability, Long Term Disability.
3% retirement contribution match
Incentive Performance Plan
10 days paid vacation accrues in your first year
10 paid sick days
8 paid Holidays
Flexible work schedule
The Director of Quality will report to Chief Operating Officer (COO)
As we prepare for FDA approval and broad scale commercial launch, we currently have an immediate opening for a Director of Quality. This is an excellent opportunity to be actively involved in the start-up and implementation of the QMS.
The Director of Quality is responsible for activities related to the Quality Management System (QMS). These relate to overall compliance with regulations put forth by the FDA, College of American Pathology (CAP)/ CLIA and standards issued by international regulatory bodies. Management of the Document and Change Control Process, oversight of batch production records and other quality records as they relate to quality issues, preparing for, conducting and hosting quality audits. This position reports on the performance of the QMS on need for improvements to the Management Representative and/or Chief Operating Officer.
Responsibilities and Duties
Develop, document, implement, and maintain quality systems and processes to ensure compliance with Company, Customer, FDA/GMP, ISO 13485, CAP/CLIA and other regulatory requirements.
Develop plans and priorities for quality assurance activities
Ensure company-wide compliance with state, federal and international regulations, and standards, as appropriate.
Manage and oversee the following:
Document Change Controls process
Quality System and day-to-day quality assurance operations
College of American Pathology (CAP)/ CLIA Accreditation and Compliance
Complaint handling process and adverse event reporting
Non-Conforming Material Report process
Corrective and Preventive Action (CAPA) system process
Calibration and maintenance of inspection and test equipment process
Supplier audit and control process
Internal audit process
Quality metrics: development, collect, maintain, trend, and analyze data
Preparation for Management Reviews
Other duties as assigned
Make recommendations to the Management and the executive team for correction of identified quality system, process, and product deficiencies and opportunities for improvement
Assist with Regulatory with pre- and post-market submissions – domestic and global submissions, periodic state, federal and international registrations
Communicate, both orally and in writing, with customers and suppliers, as appropriate
Participate in the company Management Review, as appropriate
Coordinate with other departments in examining operational or functional problems that affect product quality
Participate in product development and other interdisciplinary teams
Prepare and communicate performance reviews for departmental personnel
Ensure department personnel are adequately trained in the performance of their jobs
Bachelor’s degree (BA/BS) from a four-year college, university, or Trade School; at least five years related experience and/or training; or equivalent combination of education and experience
Expertise with Good Manufacturing Practices (GMP) and Good Documentation Practice (GDP)
Expertise in FDA 21 CFR 820, Quality System Regulation (QSR) requirements
General understanding of College of American Pathology (CAP)/ CLIA Requirements and Compliance
Knowledge of ISO 13485
General understanding of ISO 14971, Risk Management for medical devices
Excellent written and verbal communications skills
Works well independently and in a team environment
Strong organizational skills and attention to detail
Experience with Microsoft Office applications including Excel, Word, Power Point, Sharepoint and Outlook
Experience in a regulated environment such as FDA and/or ISO 13485
Prefer internal quality auditor or lead auditor certification in a regulated environment
Basic knowledge of the manufacturing/operations process, including inspection methods; understanding of MRP/ERP systems a plus
Knowledge of root cause investigations
Employee should be able to sit and stand comfortably and able to lift up to 25 pounds.