United Spinal Association Jobs

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.

Essential Functions:

• Participate in resource planning, recruiting, and budgeting. Attend project meetings and establish activity timelines to meet department and company Goals and Objectives

• Keep executive staff informed of any issues that adversely impact the Quality

• Provide leadership, guidance, and support for the quality engineering team

• Prioritizes supports and facilitates the workload to Senior Quality Engineers, Quality Engineers, Asc. Quality Engineers, and Quality Engineering technicians within their Value Stream or Work Stream

• Reviews and approves monthly quality objectives slide decks and reports to senior management

• Reviews Design transfer activities to ensure that all deliverables have been met prior to release

• Reviews and Authorizes Engineering Change Orders, Manufacturing Change Orders, Source of Supply, Control Plans, PFMEA’s, SOP and Procedure change requests

• Review’s nonconformance investigations and corrective actions.

• Develops team members by training them in Quality Sciences, Problem Solving/Six Sigma (PDCA), cGMP and other technical requirements

• Reviews and approves Quality Plans, Validation Protocols, Test Reports, Engineering Studies and TMV’s

• Perform internal and supplier audits

• Create and/or execute Quality Plans

• Disposition, perform containment, and evaluate the risk of nonconforming material

• Identify root cause and corrective action by supporting the CAPA process

• Work with manufacturing engineers to implement risk analysis, manufacturing control plans, and inspection plans for in-process and final inspection

• Work with manufacturing engineers to evaluate process risk through supporting PFMEA activities

• Support Quality and Manufacturing Engineering to write and Execute Test Method Validation protocols and reports

• Create and/or execute Engineering studies, Protocols and Test reports

• Coordination with the Quality Control department to resolve general concerns

• Support Inspections and Audits

• Support and evaluate process changes for qualification

• Create and updates SOP’s, WI, and forms as required

• Supports process development with design transfer activities

• Supports FDA and ISO 13485 inspections/audits

• Creates and updates SOP’s, WI, and forms as required

• Performs inspections as needed, or ensures that inspections are performed by qualified personnel, and that inspection results and documentation support the recommended disposition action

• Designs and procures production gaging when appropriate

• Evaluate and qualify manufacturing processes to ensure technical requirements can be met (MSA, Cpk, assembly validation, etc) Provide process development and operations with inspection criteria prior to manufacturing

• Manage process validations and process improvements

• Planning, execution, and responding to QMS documents and problem resolutions

• Planning, execution and ensuring department goals and objectives are met

• Train, guide, influence and mentor Jr. or new Quality Engineers

• Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485, 21 CFR 820, and the European Medical Device Regulation

• 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 uphold 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.

Required Skills / Capabilities:

• Knowledge of Statistical Analysis required

• Computer literate (i.e. MS Word, MS Excel, MS PowerPoint)

• Expertise in interpreting and applying GD&T

• Proficient and accurate with word processing (Word), spreadsheets (Excel), charting, flow charting, and graphs. Competency in navigating the Internet

• Experience in electronic QMS and ERP systems

• Strong mathematical skills, including statistics. (Tolerance analysis, significance tests, process capability, sampling plans, GD&T).

• American Society for Quality CQE, CQA and or CQM highly desirable

• Strong understand of ISO 13485, CFR 21 820, and/or MDR.

• Strong manufacturing background

• Clean room experience

Education and Experience:

• Requires a bachelor’s degree or comparable experience in a business, science, technical, or engineering discipline (e.g. BSIE, BSME, BSEE, or BSBME)

• Minimum 5 years of related experience in the medical device industry

• Proven track record of leadership and managing teams industry

• Working knowledge of United States and international regulations and standards (i.e. QSR, ISO13485, and MDR) required

Travel and/or Physical Demands:

• Up to 10% travel as required

• Lift up to 25 lbs

• Walking, standing, manufacturing environment

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.