Quality Assurance Specialist

Job Summary:

Right Way Medical is seeking a highly skilled and detail-oriented Quality Assurance Specialist. As a Quality Assurance Specialist, you will be responsible for ensuring that our processes and procedures meet the highest quality standards and comply with all relevant regulations. Your expertise in ISO standards and quality management will be crucial in maintaining our commitment to excellence.

Right Way Medical is a fast paced, multi-tasking, and team-oriented company with ten years of significant growth and tremendous opportunities to define your own career, yet the atmosphere is relaxed and fun within a comfortable and friendly office. Right Way Medical was among the fastest growing private companies in central Ohio (Columbus Fast 50) in 2017, 2018, 2019, 2020, 2021, and 2022.

Responsibilities:

• Promote quality performance within the company.
• Conduct internal audits and ensure Audit Schedule is up to date.
• Supervise QA audit personnel assignments.
• Collect and report data for quality levels, incidents, and /or non-conformance.
• Manage training for ISO processes.
• Ensure the process of QA audit records are accurate and properly retained.
• Manage training files (hardcopy and digital records) for employees.
• Utilize the inventory quarantine and any physical means needed to ensure materials and product requiring hold and release are controlled until QA approval to release.
• Communicate internally and to customers for approvals and reporting of issues requiring resolution.
• Report non-conformance of product and materials to suppliers and customers for corrective action.
• Analyze client complaints and perform root-cause investigations to provide upon request.
• Maintain records of Testing Frequency and Logs such as Calibration, Validation, Non-Conformance and Document Control.
• Manages Environmental Monitoring Program. (EMP’s) and Pest Control.
• Develop and update CAPAs, SOPs, Work Instructions, Job Aids and Controlled Forms.
• Additional duties may be assigned.

Requirements:

- Bachelor's degree

- Proven experience in Quality Assurance

- In-depth knowledge of FDA regulations and quality management systems

- Proficiency in using NetSuite

- Strong analytical skills with the ability to interpret complex data sets

- Excellent problem-solving abilities with a keen attention to detail

- Familiarity with ISO principles is a plus

We offer competitive compensation and benefits packages, including medical/dental/vision insurance, retirement plans, and opportunities for professional development. Join our team of dedicated professionals committed to delivering high-quality products that meet the needs of our customers.

Note: This job description is intended to provide a general overview of the position and does not encompass all tasks or responsibilities that may be required.

Job Type: Full-time

Pay: $52,000.00 - $62,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 1 year

Schedule:

• Monday to Friday

Work setting:

• In-person
• Office

Ability to Relocate:

• Westerville, OH 43081: Relocate before starting work (Required)

Work Location: In person