Quality Engineer

NuVasive Clinical Services Monitoring, Inc.; Memphis (TN); On-site; USD 70,000 - 95,000; Full time

Job summary

Globus Medical is seeking a quality assurance professional to design, implement, and maintain QA protocols for materials to finished products. You will guide compliance with safety, quality, and regulatory standards for worldwide distribution and assist in reporting issues and improvements across production processes.

The role involves reviewing changes for validation, performing inspections, investigating complaints, supporting CAPA and design control activities, and contributing to quality

Qualifications

• Proficient in computer technology including MS Office applications.
• Strong attention to detail and analytical skills.
• Ability to work effectively in a team; good organizational skills.
• Experience with FDA/state regulations and ISO 13485 is preferred.
• Typically requires a bachelor’s degree and related experience.

Responsibilities

• Reviews product and process changes for qualification and validation requirements.
• Implements systems to ensure timely quality inspections for materials and finished goods.
• Conducts investigations into complaints or audit issues as quality feedback.
• Supports non-conforming material program and design control activities.
• Assists with quality initiatives and documentation for process improvements.
• Ensures compliance with FDA, state regulations, and ISO 13485 standards.

Skills

MS Office

Analytical skills

Teamwork

Detail oriented

Regulatory knowledge

Education

Bachelor's degree in engineering

Job description

Position Summary:

Designs, implements, and maintains quality assurance protocols and methods for processing materials into finished products. Guides the compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standard requirements for worldwide distribution. Inspects, tests and evaluates the precision and accuracy of production processes and equipment. Supports the analysis of reports and production data to help identify trends and recommend updates or changes to quality standards and procedures. Upholds the company's quality standards and testing systems to reflect efficiency, reliability, and performance. Assist in the creation of documentation to report issues and errors relating to the production process.

Essential Functions :

• Reviews product and process changes for qualification and validation requirements and assists in change implementations.
• Implement systems to ensure timely quality inspections for incoming materials, components or finished goods products, and perform inspections as needed.
• Conduct investigations into complaints or audit issues as quality system feedback is provided.
• Supports the Non-Conforming Material program and general Design Control activities such as risk assessment, design verification, and validation, as well as sterilization and packaging validation.
• Assists with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products.
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
• Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.
• Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions .

Qualifications:

• Proficient in computer technology including MS Office applications, with good analytical and problem-solving skills.
• Able to work efficiently in a team environment.
• Strong attention to detail and good organizational skills
• Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485
• Typically requires a bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.
• Bachelor's degree in engineering discipline

Physical Demands :

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

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Required to possess specific visons abilities, including close vision, distance vision, color vision, peripheral vision, depth perception, and capacity to adjust focus."

Our Values :

• Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
• Customer Focused : We listen to our customers’ needs and respond with a sense of urgency.
• Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
• Driven : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Equal Employment Opportunity :

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.

Other Duties :

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.