Quality Specialist

Our team is growing, and we currently have an immediate opening for a Quality Specialist

Title

Quality Specialist

Location

Onsite-Cleveland Office

Reports To

Director of Quality Assurance

Job Overview

Participate in activities supporting the successful implementation and maintenance of the quality management system (QMS) in compliance with current ISO13485, EU IVDR, and 21 CFR 820 requirements.  Create, review, and manage documentation related to the QMS.  Participate in cGMP and quality related activities.  Requires excellent attention to detail, critical thinking, risk-based decision making, communication, and a consistent quality minded approach.

Essential Duties & Responsibilities

Supplier Management :   Support the supplier management process including related activities for qualification, audits, surveys, change control, corrective actions, and the approved supplier list (ASL).

Internal Audit Program :   Schedule and perform internal quality audits, assist in the resolution of audit findings, and manage the resulting records and supporting evidence.

Batch Record Review :   Perform comprehensive Quality review of completed batch records and associated production records.

Corrective and Preventive Action (CAPA) :   Support identification and resolution of events, perform root cause investigation, determine corrective action plans, and facilitate on time closure.

Deviations :   Support identification and resolution of events, perform risk and impact assessment, implement immediate corrections, perform root cause investigation, determine corrective action plans, and facilitate on time closure.

Documentation :   Coordinate, manage, and perform quality review of controlled documents and records.

3rd Party Audits :   Participate in QMS audits of Cleveland Diagnostics by regulators, customers, Notified Bodies, or registrars (ISO certification and surveillance audits).

Nonconforming Product :   Assist all departments to identify, investigate, document, and resolve nonconformity events.

Change Control :   Support the change control process to determine and address the potential risks and impact of changes to product design, materials, processes, systems, equipment, etc.  This includes the management of associated records and supporting documentation.

Training :   Coordinate initial QMS training for new hires, assist all departments to manage employee training, and coordinate refresher training.

Complaint Files :   Support complaint records, perform root cause investigations, and determine corrective action plans.

Quality Management Review :   Support information gathering and analysis for the QMS management review process.

Quality Oversight :   Perform Quality checks of manufacturing activities including label verification, final release inspection, and records review.

Continuous Improvement : Participate in the creation, revision, and implementation of procedures, forms, and work instructions to improve current processes.

Prepare for and participate in QA-related activities.

All other duties as assigned

Working Relationships

• Interacts frequently with employees across and at all levels within the organization
• Collaboration expected to resolve identified issues and events
• Participates in cross-functional teams
• Does not have direct reports

Work Environment / Physical Requirements :

Bachelors degree in a scientific discipline such as chemistry, biology, or engineering

4 years of experience in a Quality role within a US FDA regulated industry such as medical device or pharmaceutical manufacturing

Working knowledge and experience with Quality Management Systems (QMS) such as 21 CFR 820, ISO13485, or EU IVDR

Working knowledge and experience with current good manufacturing practices (cGMP) and good documentation practices (GDocP)

Excellent verbal and written communication skills

Excellent computer proficiency with Microsoft Office products

General office and HVAC noise

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.  We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employees well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

Cleveland Diagnostics offers an extremely robust benefits package which includes :

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law.  Applicants can learn more about the companys status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page.   Accommodations are available for applicants with disabilities.

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