Quality Assurance Specialist - Medical Device

About the Role

The QA Specialist is responsible for performing Quality compliance activities on the production floor and ensuring that all activities are in compliance with company and regulatory guidelines and procedures. In addition, the QA Specialist assists in activities directly related to in-coming product/kitting release, batch record, and procedure review. Reports to the QA Manager – Medical Device. Location: Johnson City, TN. Hours: Monday-Friday, 8AM-4PM.

Responsibilities

• Perform audits/checks of incoming and in-process processes, including QA checks, line clearance activities, record review and signoff, label verification, and reconciliation verification.
• Perform Safe Launch and Safe Exit inspections for specified products.
• Receipt and inspection of RMA material.
• Approve minor deviations on the operation floor.
• Review and approve executed batch records for completeness and accuracy for batch release.
• Verify and ensure compliance with regulatory and company procedures and guidelines.
• Assist with training floor personnel in GDocP.
• Perform investigations as required.
• Assist in other quality-related functions as requested.
• Assist in the kitting area, reporting to the area leadership team, with time utilization shared with the kitting department as needed.
• Additional tasks as assigned by Quality Management and/or Kitting Leadership.

Qualifications

• Minimum of 0-2 years’ experience in Quality Assurance, Manufacturing, or a regulated industry.
• Demonstrated knowledge of cGMPs and other regulatory requirements for the manufacture, testing, and release of Crown Aesthetics products.
• Strong proficiency in Microsoft Office suite (Word, Excel, PowerPoint).
• Excellent verbal and written communication skills.
• Excellent interpersonal, communication, and organizational skills, as well as the ability to work independently.
• Ability to stand for several hours, lift approximately 20 lbs repetitively, and unstack/restack pallets to pull ANSI AQL samples.

About the Company

Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

Benefits

• Competitive compensation, including base salary and annual performance bonus.
• Paid time off, holidays, and floating holidays.
• Generous healthcare benefits, employer HSA match, 401k match, and wellness discounts.

Revance is an equal opportunity employer. We value diverse backgrounds, experiences, and viewpoints. Revance does not discriminate in practices or employment opportunities based on race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.