Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!
What You Can Expect
The Quality Control Specialist position is responsible for performing all testing for raw materials, in-process product and finished medical devices as well as routine environmental monitoring of the controlled production spaces to ensure they conform to all applicable laws and company standards. All these activities are conducted in an FDA regulated and ISO 13485 certified environment. This position supports Manufacturing and Quality by performing and documenting all quality control activities in the GMP environment using standard work instructions, forms, reports and the Enterprise Resource Planning/Management (ERP) system. This position requires high proficiency in the operation of various laboratory and labeling equipment, usage of multiple software platforms and other tasks in support of the production and distribution schedule. This person will comply with safety requirements, current Good Manufacturing Practices and Standard Operating Procedures. They will help develop, implement, and perform new procedures to streamline and improve the quality control processes as the company grows. The quality control specialist will further support Manufacturing and Quality by working on cross functional teams to investigate and resolve non-conformances, audit findings and CAPAs.
How You'll Create Impact
- Responsible for performing the incoming inspection QC tests for critical supplies
- Understand and utilize Acceptance Sampling Plans
- Benchtop testing such as SDS-PAGE and functional testing
- Review of raw material certificates of quality/conformance/analysis
- First article inspection for materials with critical dimensions
- Mechanical testing of incoming packaging materials
- Documentation of all testing and material certificate review
- Responsible for performing In-Process and Finished Goods QC tests
- Visual & dimensional inspection
- Mechanical testing using biomechanical test equipment
- Scanning electron microscopy
- Endotoxin testing
- Documentation of all testing including deviations and results
- Responsible for environmental monitoring of cleanrooms and controlled production spaces
- Viable and non-viable air monitoring
- Surface microbial monitoring
- Characterization of microbial strains found during routine monitoring
- Track and trend all environmental monitoring data
- Initiate and participate in non-conforming material and root cause investigations
- Initiate and assist in ongoing production & quality process improvements and subsequent validation activities
- Participate in non-conformance, CAPA and Customer Feedback investigations as they relate to quality control
- Work with engineers, technicians, and management to identify root causes, resolve issues and suggest improvements
- Implement corrective and preventive actions as required · Participate in production and quality planning meetings as needed
- Maintain accurate quality control records and documentation
- May interact with external customer contacts such as
- Participating in tours for visitors including VIPs
- May be questioned and/or observed during audits
- Adhere to general safety rules, manufacturing procedures, company policies and procedures, ISO and FDA regulations
What Makes You Stand Out
- Bachelor’s Degree in Biological Science, Chemistry or Medical Technology preferred
- Minimum (2) years working in a R&D or quality control department
- Preferred (2) years working with an electronic quality control management system
- Preferred (1) year experience doing quality control in the medical device industry
- Ability to follow SOP’s, work instructions, and maintain daily records in a timely and reliable fashion
Your Background
- Must be a highly organized individual who works independently with minimum supervision in a fast-paced environment
- High level of competency with Microsoft Office and database programs
- Excellent communication skills both written and verbal
- Comfortable working under an ISO 13485 or 9001 Quality Management System
- Comfortable working with cross functional groups with staff from all educational and professional backgrounds
Working Conditions
- 40 hours a week with additional hours as required by production schedule
- Office, cleanroom, and laboratory setting
- Ability to stand for prolonged periods of time
- Ability to lift up to 75lbs
EOE/M/F/Vet/Disability
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