Quality Engineer
NuVasive
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
Position Summary:
The Quality Engineer assures that all Globus products and processes meet the highest regulatory and internal standards by rigorously applying engineering principles across multiple different elements of the business. Partnering primarily with Product Development, the Quality Engineer will ensure the smooth operation of existing product lines as well as guide the introduction of all new products with respect to the company’s quality system.
Essential Functions:
Reviewing inspection processes and issues; Creating and providing guidance on inspection sheets and gauging
Attending on or off-site vendor meetings when required to evaluate and discuss product and manufacturing quality
Implement and complete Part Process Performance Qualifications with vendors as well as other process validations as needed
Performing quarterly analysis of all field complaints to identify trends in cause of returns; Recommending changes to design based on complaint investigation
Performing quarterly review of vendor NCMRs to identify trends in reasoning for non-conformance
Leading the investigation of reoccurring product problems. Work with Product Development team to identify and manage corrective actions resulting from problem investigation including CAPA’s, FMEA, and SCAR initiation and review
Participating in design reviews and manufacturing meetings to evaluate design and to help identify alternative design solutions
Participating in verification and validation efforts to identify and mitigate areas of risk
Maintaining product DHF’s and ensure risk management, line extension, design review, and other associated documentation are included and up to date
Reviewing and conducting post market surveillance activities
Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure 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
Representing the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:
Bachelor’s Degree required (science or engineering preferred)
3-5 years’ experience in quality assurance; experience in the medical device industry preferred
GMP and ISO experience
Strong proficiency in MS Office with knowledge of statistical analysis tools
Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering is a plus
Must be a team player capable of working in a deadline dictated environment
Excellent verbal and written communication skills
Our Values:
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
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.