Senior Quality Specialist

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

Title

Senior Quality Specialist

Location

Onsite-Cleveland Office

Reports To

Head of Quality Assurance

Job Overview

Coordinate and lead activities supporting the successful 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: Manage supplier related processes including activities for qualification, audits, surveys, change control, corrective actions, and the approved supplier list (ASL).

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

• Batch Record Review / Product Disposition: Perform comprehensive Quality review of completed batch records and associated production records, including batch disposition decision-making.

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

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

• 3rd Party Audits / Inspections: Participate in QMS audits of Cleveland Diagnostics by regulators, customers, Notified Body, or registrars (ISO certification and surveillance audits), and lead the remediation of audit findings.

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

• Change Control: Manage 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, coordinate refresher training, and present on quality related topics.

• Complaint Files: Manage complaint records, perform root cause investigations, determine corrective action plans, and lead remediation activities.

• 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, product 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
• Leads and participates in cross-functional teams
• Does not have direct reports

Preferred Skills, Education, and Experience:

• Bachelor's degree in a scientific discipline such as chemistry, biology, or engineering.
• ≥ 8 years of experience in a Quality role within a US FDA regulated industry such as medical device or pharmaceutical manufacturing.
• Extensive knowledge and experience with Quality Management Systems (QMS) such as 21 CFR 820, ISO13485, or EU IVDR.
• Extensive 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.

Work Environment / Physical Requirements:

• Position is on-site

• Office environment with occasional visits to the laboratory or manufacturing areas.

• Supplier audits require occasional domestic and or international travel.

• Primary activities are performed at a desk and include use of standard office equipment (computer, phone, photocopiers, filing cabinets, etc.).

• May include periods of walking, standing, sitting, climbing stairs, and or light lifting.

• Requires personal protective equipment (PPE) when visiting the manufacturing or laboratory areas.

• Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples)

• General office noise, HVAC and fluorescent lighting; offices reachable by elevator but should be able to climb stairs in case elevator out

• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.

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Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. 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 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:

• 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
• 100% Employer-paid Dental & Vision for entire family
• No cost for employee coverage for Group Term Life, Short & Long Term Disability
• 4% retirement contribution Employer match
• Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
• Paid Family Leave Program
• Generous PTO plan & holiday program
• Flexible work schedule & lucrative employee referral program
• Salary range may vary by work state/geographical region/territory
• Easy to get to office location with newly built-out office space
• Free coffee, snacks and other goodies all day long

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 company's 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.

Compensation details: 75000-100000 Yearly Salary

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