Senior Quality Specialist
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 requires attention to detail, critical thinking, risk-based decision-making, communication skills, and a consistent quality-minded approach. The position is based onsite at the Cleveland office and reports to the Head of Quality Assurance. It 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 work is primarily performed at a desk in an office, with occasional visits to laboratory or manufacturing areas. Supplier audits may require occasional domestic or international travel. The role uses standard office equipment and may involve walking, standing, sitting, climbing stairs, or light lifting. Personal protective equipment is required when visiting manufacturing or laboratory areas, and Hepatitis B vaccination or an appropriate waiver is required because the work involves blood-based samples.
Requirements
- 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 safely and successfully perform essential job functions consistent with applicable ADA, FMLA, and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards.
- Hepatitis B vaccination or an appropriate waiver is required for work involving blood-based samples.
Nice To Haves
- Bachelor’s degree in a scientific discipline such as chemistry, biology, or engineering.
Responsibilities
- Manage supplier qualification, audits, surveys, change control, corrective actions, and the approved supplier list.
- Schedule and perform internal quality audits, support resolution of findings, and manage audit 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 remediation, and drive timely closure.
- Support deviation identification and resolution; conduct risk and impact assessments, implement immediate corrections, investigate root causes, determine corrective action plans, carry out remediation, and drive timely closure.
- Coordinate, manage, and perform quality reviews of controlled documents and records.
- Participate in QMS audits and inspections conducted by regulators, customers, Notified Bodies, or registrars, and lead remediation of audit findings.
- Assist departments in identifying, investigating, documenting, and resolving nonconformities involving events, products, and materials.
- Manage change control and assess and address potential risks and impacts of changes to product design, materials, processes, systems, and equipment; manage 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 coverage for single coverage effective on the date of hire; 50% employer-paid medical coverage for spouse or dependent coverage.
- 100% employer-paid dental and vision coverage for the entire family.
- No-cost employee coverage for group term life, short-term disability, and long-term disability.
- 4% employer retirement contribution match.
- Incentive Performance Plan and Stock Option Program; commission is available for Sales Account Executives.
- Paid Family Leave Program.
- Generous PTO and holiday program.
- Flexible work schedule.
- Employee referral program.
- Newly built-out office space.
- Free coffee, snacks, and other goodies throughout the day.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
