Senior Quality Engineer - East Point, United States - Facet Medical Technologies LLC

Description

POSITION TITLE

Senior Quality Engineer

REPORTING RELATIONSHIPS

This position reports to the Senior Director of Quality Engineering and Engineering

CLIENT OVERVIEW

Facet Medical Technologies is a medical device company that serves the global diabetes care, wound care, and drug delivery marketplaces.

Our mission is to improve lives by making medical devices which contribute to improved diagnostics and therapy.

With a 50-year heritage, Facet Medical is proud to be one of the largest providers of lancets and lancing devices in the world. Facet desires to deploy business models that make our products accessible across the globe, while providing an opportunity for growth and development for our employees, all with the highest level of quality.

Facet maintains a high-end quality and ultra-clean work environment as we manufacture medical devices with oversight by the FDA. Headquartered in Atlanta, GA, Facet Medical designs, manufactures, and markets products and services to the industry's premier OEMs and retailers.

Our company is growing and scaling up current and new product lines in the Lancet, Continuous Glucose Monitoring (CGM), and Wound Care markets, which is exponentially growing annually. It is an exciting time to join our team

Facet leverages our product intellectual property, high volume manufacturing capabilities, and global supply chain to deliver our products and services across the globe.

LOCATION

Corporate Headquarters, East Point, GA

POSITION IMPACT

As our client continues its dynamic growth and expansion as an industry leader, this role is pivotal in ensuring the adherence to stringent quality standards, regulatory compliance, and safety protocols throughout the product lifecycle. Your strategic contributions will not only optimize operational efficiency and reduce costs, but also bolster patient safety and product efficacy through championing best practices in quality engineering.

The Senior Quality Engineer will leverage extensive experience in quality management systems and regulatory requirements, to spearhead initiatives aimed at continuous improvement and risk mitigation. Through analytical prowess, meticulous data analysis, and root cause investigations, will facilitate the identification of areas for enhancement, and implement effective corrective and preventive actions. Through collaboration with cross-functional teams, the Senior QE will foster a culture of excellence and accountability.

FUNCTIONS AND RESPONSIBILITIES

The Senior Quality Engineer position will be the first line of defense for any quality issues and will be the foundation and anchor for the quality engineering group. This senior member of the team will plan and direct activities concerned with the development, application, and maintenance of the quality processes, materials, and products. In addition, will hold accountability for investigating manufacturing and customer nonconformances, determining root causes and corrective actions, reviewing and approving protocols and final reports, and developing product specifications and sampling plans.

Specific functions and responsibilities of the position include:

• Reviewing and approving validation protocols and final reports for equipment, product, and processes
• Investigation of manufacturing and customer non-conformance complaints through root cause analysis (RCA)
• Resolution and continuous improvement for root cause analysis, including Non-conformance Reports (NCR) and compliance
• Development and implementation of corrective action necessary to resolve NCR/CAPA issues
• Completion of effectivity checks for all root cause analysis, CAPAs and document findings
• Formulating responses to customer complaints
• Facilitating improvement projects and teams
• Interacting with customers and suppliers routinely to ensure that product quality is continually maintained
• Addressing all product quality issues for current products and maintaining all quality functions related to packaging and manufacturing
• Participating in FDA inspections, ISO audits, and customer audits of the plant quality system
• Performance of supplier and internal audits, generating audit reports, and management of responses
• Developing and initiating standards and methods for inspection, testing, and evaluation
• Developing product specifications and sampling plans. Will devise sampling procedures, and design/develop forms and instructions for recording, evaluating, and reporting quality and reliability data
• Program establishment to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities
• Development and implementation of methods to assess cost and accountability
• Directing teams engaged in measuring and testing products and tabulation of data concerning materials, product, or process quality and reliability

PROFESSIONAL QUALIFICATIONS

The ideal candidate for this Senior Quality Engineer position should possess a minimum of 8 years of relevant experience in quality engineering or related fields. They must demonstrate a thorough understanding of Quality System Regulations (QSR), ISO 13485, CFR 820, and EU MDD/MDR regulations.

Proficiency in process improvement methodologies, Statistical Process Control (SPC), and other statistical process methods is essential. Experience in medical device manufacturing, biological evaluations, insert molding, CQE/CQA certifications are preferred.

Additionally, expertise in process and product validations, as well as the development of Measurement Systems Analysis (MSA), Gauge Repeatability and Reproducibility (GR&R), and Test Methods is required.

Experience in conducting Supplier/Internal Audits is highly beneficial.

PERSONAL CHARACTERISTICS

We seek a Senior Quality Engineer who brings a growth mindset and possesses sound judgment, humility, and will be a great fit into Facet's corporate culture. These characteristics will include:

• Superior verbal and written communication skills
• Excellent time management
• Proactive and effective approach to problem solving
• Demonstrated detail orientation and accuracy ensuring quality of work
• Internal drive to always do better, take initiative to improve, learn more, take on additional responsibilities, and drive projects forward to successful conclusion.
• Respectful to others, works to find common ground when dealing with issues. Known as a team player, and works well with other functions
• Safety focus, following all program guidelines, processes, and procedures

EDUCATION

Bachelor's degree in engineering, science, or related technical field required, with an advanced degree preferred

COMPENSATION

Our client offers a competitive salary commensurate with experience