Senior Quality Specialist

Cleveland Diagnostics•Cleveland, OH

4d•Onsite

About The Position

The Senior Quality Specialist coordinates and leads activities supporting the successful maintenance of the quality management system (QMS) in compliance with current ISO 13485, EU IVDR, and 21 CFR 820 requirements. The role creates, reviews, and manages QMS documentation and participates in cGMP and other quality-related activities. It calls for excellent attention to detail, critical thinking, risk-based decision-making, communication, and a consistent quality-minded approach. The position works frequently with employees across all organizational levels, collaborates to resolve issues and events, and leads and participates in cross-functional teams. It has no direct reports. The role is onsite at the Cleveland office, with occasional visits to laboratory or manufacturing areas and occasional domestic or international travel for supplier audits. Primary activities take place at a desk using standard office equipment; visits to manufacturing or laboratory areas require personal protective equipment and Hepatitis B vaccination or an appropriate waiver.

Requirements

Bachelor’s degree in a scientific discipline such as chemistry, biology, or engineering.
At least 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 QMS requirements such as 21 CFR 820, ISO 13485, 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.
Ability to meet qualitative and/or quantitative productivity standards and perform essential job functions consistent with the ADA, FMLA, and applicable federal, state, and local standards.
Ability to climb stairs if the elevator is unavailable.
Hepatitis B vaccination or an appropriate waiver is required because the role involves working with blood-based samples.

Responsibilities

Manage supplier processes, including qualification, audits, surveys, change control, corrective actions, and the approved supplier list.
Schedule and perform internal quality audits, support resolution of audit findings, and manage related records and supporting evidence.
Review completed batch records and associated production records, including making batch disposition decisions.
Support CAPA identification and resolution, conduct root cause investigations, determine corrective action plans, carry out remediations, and drive timely closure.
Support deviation identification and resolution; perform risk and impact assessments, implement immediate corrections, conduct root cause investigations, determine corrective action plans, carry out remediations, and drive timely closure.
Coordinate, manage, and perform quality reviews of controlled documents and records.
Participate in QMS audits by regulators, customers, Notified Bodies, or registrars, and lead remediation of audit findings.
Assist departments in identifying, investigating, documenting, and resolving nonconformity events, products, and materials.
Manage change control to assess and address risks and impacts of changes to product design, materials, processes, systems, and equipment, including associated records and documentation.
Coordinate initial QMS training for new hires, assist departments with employee training, coordinate refresher training, and present quality-related topics.
Manage complaint records, conduct root cause investigations, determine corrective action plans, and lead remediation activities.
Support information gathering and analysis for QMS management reviews.
Perform quality checks of manufacturing activities, including label verification, product inspection, and records review.
Participate in creating, revising, and implementing procedures, forms, and work instructions to improve processes.
Prepare for and participate in QA-related activities.
Perform other duties as assigned.

Benefits

100% employer-paid medical insurance for single coverage effective on the date of hire; 50% employer-paid medical coverage for spouse/dependents.
100% employer-paid dental and vision coverage for the entire family.
No-cost employee coverage for group term life, short- and long-term disability.
4% retirement contribution and employer match.
Incentive Performance Plan and stock option program.
Paid Family Leave Program.
Generous PTO and holiday program.
Flexible work schedule.
Employee referral program.
Office coffee, snacks, and other refreshments.