Compliance & Quality Engineer

COMPLIANCE & QUALITY ENGINEER

Overall Responsibilities

Generate documentation and systems for compliance with FDA Medical Device Regulations (including the current Good Manufacturing Practice (cGMP)), ISO 13485, European regulatory requirements (Medical Device Regulation (MDR), ISO 9001 and any other applicable global standards. Responsible for the creation and maintenance of all documentation and material required for the continued qualification to ISO 13485, MDR, and ISO 9001. Additionally, responsible for Quality Inspections and overall Quality Assurance of the facility.

Essential Duties & Responsibilities include the following:

• Compliance with standards and regulations established by the Company and/or relevant regulatory bodies.
• Responsible for the creation and maintenance of Quality Management System (QMS) documentation for ISO 13485, MDR, and ISO 9001.
• Responsible for ensuring that staff are trained in the latest editions of our QMS documentation and understand both the Company Quality Policy and Quality Objectives.
• Responsible for the creation and maintenance of all device master records and technical files to comply with applicable regulatory and ISO requirements at the direction of the Engineering Manager.
• Create, review, and approve device history records including but not limited to: Receiving Inspections, COC, COO, Testing Inspections/Reports, Label Validations, Work Orders, Production Control worksheets, etc. when the Technical Director and Management Representative are unavailable.
• Record, investigate, analyze, determine corrections, corrective action and preventive action and non-conformances.
• Assist in analyzing and evaluating information concerning manufacturing problems corrective actions and preventive actions, quality system concerns, etc. for review by appropriate management personnel.
• Assist manufacturing and planning in inspection and testing activities to ensure continuous control over materials, facilities, and products.

Qualifications

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education & Experience

• Bachelor’s Degree in an Engineering discipline with minimum 7 years company experience.
• 5-7 years working in a company with quality systems within an ISO environment.

Communication Skills

• Ability to generate, read, and interpret QMS documentation, both to establish new documentation and to ensure current documentation is sufficient.
• Demonstrated ability to create technical documentation electronically and all necessary data that can be used for the production facility to manufacture the product.

• Must have good communication skills, being able to take complex regulations and standards, and translate them to easily understood policies and procedures.

Reasoning Ability

• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive number of Quality Standards and effectively communicate them in the company QMS.

Training Required

• All departmental procedures. FDA current Good Manufacturing Practice (cGMP), Unique Device Identification (UDI), ISO 13485, Medical Device Regulation (MDR), and ISO 9001.