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Job DescriptionJob Description We're looking for a motivated and collaborative Quality Systems Manager to join our growing team at Delcath. In this role, you'll have the opportunity to make a meaningful impact while working alongside talented colleagues in a supportive and innovative environment.

We're excited to provide a complete benefits package, including a comprehensive health plan, 401(k), and professional development opportunities, to support the well-being and growth of our employees and their families.

POSITION SUMMARY

Responsible for ensuring the effective establishment and maintenance of the Delcath Quality System and ensuring that the facility is fully compliant to all applicable and international regulations and standards. Responsible for maintaining the quality system in an audit ready state.

This position retains signatory authority for Quality Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

In coordination with Director of Quality, develops and executes quality and regulatory strategies and systems to comply with Quality System Regulations (QSR), Medical Device Regulation (EU MDR 2017/745), International Standards Organization (ISO), Recognized Consensus Standards and all other applicable quality system requirements. Ensures compliance to 21 CFR Part 820, 21 CFR Part 211, 21 CFR Part 4, ISO 13485, UK MDR 2002, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Manages and maintains the effectiveness of the Delcath Quality Management System and manages the resolution of all quality concerns and related issues as required. Execute day-to-day processes for medical device manufacturing facility regulatory accountabilities to ensure continual regulatory compliance with FDA, Outside US Regulatory Authorities, and Notified Body and Approved Body requirements. Lead Regulatory/Notified Body audits at the Queensbury site and provides support for Regulatory/Notified body audits at the Galway site Manages the Corrective Action and Preventive Action Program. Manages the Internal Audit Program. Manage the Supplier Quality Program. Support Customer Complaint investigations. Ensure Customer Complaint records are properly maintained, followed-up, and closed. Manages the Management Review process to monitor and evaluate Quality System effectiveness. Support the Post Market Surveillance process for the US and OUS markets. Maintains current knowledge base of all regulatory and quality assurance related changes within the industry. Monitor, review and interpret new or revised medical device regulatory requirements and proactively advise colleagues. Supports new OUS country product registrations and manages existing country registration activities. Review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; appropriately document regulatory disposition of such changes. Manages these change notifications with the Notified Body and Approved Body. Review and maintain Quality Systems programs and provide Site Regulatory SOPs to support business activities.

SUPERVISORY RESPONSIBILITIESManages employees and is responsible for the overall direction, coordination and evaluation. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

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, unless they constitute undue hardship.

EDUCATION and/or EXPERIENCE

A minimum of Bachelor’s degree in engineering or physical sciences. Experience leading FDA / Notified body audits, ideally as the main point of contact. A minimum of ten or more years of experience in quality systems, in an FDA regulated industry and ISO certified organization is required. Experience of EU MDR regulation and management of quality systems that comply to same. A minimum of three years’ people management experience and must be team oriented, with the ability to work well with diverse cross-functional teams to ensure company objectives are met. Must possess strong analytical and process skills, and be computer proficient in Mastercontrol, EXCEL, Word, etc. Must possess strong verbal and written communication skills. Must be willing to travel.

SKILLS

Ability to read and interpret documents such as technical journals, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively with employees and outside organizations.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, heat, airborne particles, moderate noise and outside weather conditions.

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