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
Reports To The Director of Quality will report to Chief Operating Officer (COO) Job Overview 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
- Training process
- 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
Qualifications - 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
Physical Requirements Employee should be able to sit and stand comfortably and able to lift up to 25 pounds. To Apply for this position, kindly email your resume to: Barbara.Horvath@ClevelandDx.com Barbara Horvath Administrative Officer (216) 432-2700 |
