Quality Control Shift Lead - 3rd Shift
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.
The Quality Control, Shift Lead is responsible for coordinating as well as performing QC inspections and testing on all manufacturing supplies, in-process materials, and finished products. This effort includes, but is not limited to, conducting tests for new product validations (process, sterility, and packaging validations), involvement in manufacturing equipment calibration and maintenance program, and aiding with the identification and development of new test procedures. The Quality Control, Shift Lead is also responsible for ensuring all policies and procedures are in compliance with applicable FDA, state, OSHA, AATB, and ISO regulations and standards.
- Trains and mentors team members
- Performs quality control inspections and testing on manufacturing supplies, in-process materials and finished products.
- Tracks and pulls weekly endotoxin test samples
- Performs QC tasks and testing for aseptic manufacturing
- Performs viable and non-viable particulate environmental monitoring in clean areas/rooms
- Performs in-house calibration and preventative maintenance on equipment
- Coordinates process improvements with both QC and MFG teams
- Coordinates HCTp rework and disposition
- Follows proper safety procedures
- Ships test samples to outside test lab
- Maintains the quality control lab and work areas in an organized manner
- Maintains up to date knowledge with respect to relevant state-of-the-art technology, equipment, and/or systems
- Drafts new test methods and procedures as needed
- 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.
- Bachelor’s Degree in chemistry, biology, biomedical engineering, materials engineering, mechanical engineering or chemical engineering required or equivalent training and experience
- Minimum of 2 years’ experience in quality control with experience in performing QC tests and inspections
- Ability to sterile gown
- Familiarity with computer-controlled test systems (mechanical testing, pH Testing, GPC analysis, porosimetry, moisture testing experience a plus).
- Excellent math skills to adequately perform and interpret calculations and test parameters
- Ability to evaluate and interpret scientific data.
- Working knowledge of Excel, Windows, and Microsoft Office applications.
- Must be a flexible team player capable of working in a deadline dictated environment.
- Excellent oral and written communication skills.
- Ability to work in a fast-paced environment while multi-tasking
- Auditing experience, a plus
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.
The physical demands listed here are representative of those that must be met by and 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 40 pounds
Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
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.
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.