Senior Quality Engineer- Birmingham

Senior Quality Engineer

RAMPART

RAMPART is a company focused on redefining radiation protection by offering advanced shielding solutions that eliminate the need for traditional lead aprons and provide total body and team protection in clinical settings. Their products are designed to seamlessly integrate into medical workflows, reduce chronic strain from heavy protective gear, and protect all personnel from scattered radiation. Built on peer-reviewed data and ergonomic innovation, Rampart aims to improve safety and performance for healthcare professionals.

Why You Should Join Us

As a Senior Quality Engineer in Birmingham, AL, you will assist with the development of quality systems, procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the manufacturing facility. The Senior Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal customers and external suppliers. This position reports directly to the Director of Quality Assurance/Regulatory Affairs. The Senior Quality Engineer will play a key role in supporting existing processes for the manufacturing of Rampart radiation shields.

What You’ll Do

As a Senior Quality Engineer, you will:

• Consistently models the core values of the company both internally and externally.

• Openly commit to and support company processes and systems.

• Revises / analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc. including providing support during internal and external audits.

• Participates in the preparation’s activities for/or interactions with regulatory agencies (FDA, Interek, etc.)

• Actively participate in Management Review & Compliance meetings

• Responds to internal or external audit observations related to the quality engineering function.

• Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.

• Supervises and supports quality assurance personnel on daily activities.

• Performs periodical audits to the line to evaluate GMPs, production controls, lot segregation and process audit. Checks the audit results of the area to ensure that the corrective and preventive actions are adequate.

• Evaluates the need of risk mitigation techniques given product classification, potential types of defects, defect frequency, severity, risk for the patient, process capacity, process controls, etc. Determines the effectiveness of these techniques in the previously
  implemented improvements.
• Responsible and owner of the risk assessment process including the realization, documentation, revision or maintenance of the current risk and documentation of the risk assessment such as FMEA of the process given the changes in the product/process.
• Collate and trend Key performance indicator data
• Performs other related duties as assigned to support the efficient operation of the organization.
• Carries out additional responsibilities and tasks assigned by management.

What You’ll Need

• A BS degree in manufacturing engineering, quality engineering, life science or related field and a minimum of 5 yrs. experience within the Medical Device Industry.

• Candidate must be highly motivated with excellent communication skills and proven ability to work as part of a team.

• Quality System Requirements (QSR), Gage R&R, ISO 13485, IQ/OQ/PQ, CTQ,

• Production NC, CAPA, Regulatory Requirements, Verification & Validation, Medical devices Engineering change process, Medical Devices Quality Management, Design controls, problem solving skills, etc.

• Quality Certification and Lead Auditor Certification while not mandatory would be an advantage.

Perks of the Job

Compensation Package: 

• Base: Flexible to experience, up to $116,500

• Variable commission included on top of base (% of base annually)