Quality Specialist

Cleveland Diagnostics•Cleveland, OH

7d•Onsite

About The Position

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.

Requirements

Bachelor’s 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

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

Benefits

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