Quality Assurance Specialist

Meet the Team

The Quality Assurance Specialist is a key member of the Quality and Regulatory team, reporting directly to the Quality Manager. This role shares responsibility with other Quality Assurance Specialist team members.

About the role:

As a Quality Assurance Specialist at Spinal Elements, the role involves reviewing and approving all products before shipment. Core responsibilities include:

• Ensuring compliance with Good Documentation Practices (GDP) in Device History Records (DHR) for both internal and contract manufacturers.
• Coordinating and maintaining equipment calibration and preventive maintenance.
• Maintaining environmental monitoring of subcontractors' cleanrooms (CER).
• Coordinating and maintaining microbiology testing and monitoring.
• Developing and maintaining the Approved Supplier List (ASL) and ensuring all suppliers meet the qualification standard, this includes conducting supplier audits.
• Coordinating and monitoring nonconforming products, ensuring appropriate actions (e.g., RTV, rework, scrapping) are documented and carried out, including timely evaluation, material disposition and closure.
• Assisting QC Inspectors when required.
• Assisting in internal audits to ensure compliance with internal policies, FDA regulations, and ISO standards (e.g., ISO 13485 for medical devices).
• Promoting a culture of continuous improvement, focusing on product quality, safety, and customer satisfaction.
• Complete a wide range of tasks with little instruction and only general instruction on new assignments.
• Performs core responsibilities which are moderately difficult, requiring judgement in resolving issues.

What Makes You Successful (KSA’s)

• Substantial understanding of ISO 13485, 21 CFR 820 and SEI quality system requirements.
• Proficient in Medical Device technical writing.
• Ability to communicate
• Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
• Ability to work with cross functional teams for developing strategies to evaluate product.
• Ability to work independently and as a member of a team in a timeline-driven environment with no direct oversight.
• Being detail-oriented while having the ability to handle multiple projects/tasks
• Demonstrate high quality standards.
• Working knowledge of software programs including, MS Word and Excel (Pivot Tables, Dynamic Tables) and Google applications. Participate effectively as a team player with knowledge and expertise.
• Strong understanding of compliance processes in a medical device environment such as non-conforming products, CAPA, suppliers monitoring, calibration, preventative maintenance and internal audits.
• Strong Understanding of Good Documentation Practices (GDP) to apply knowledge when evaluation Device History Records (DHR).

Experience and Education

• Bachelor’s degree (desirable).
• Minimum of 3 years of related experience

Work Authorization

US Work Authorization required.

Physical Demands

• While performing the duties of this job, the employee is regularly required to stand, walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
• Must be able to lift up to 25lbs.

Work Environment

This job operates in a warehouse setting.

Travel

Limited travel required; less than 15% of the time.

Spinal Elements is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.