At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.  

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards.  We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

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 suppliesUnderstand and utilize Acceptance Sampling PlansBenchtop testing such as SDS-PAGE and functional testingReview of raw material certificates of quality/conformance/analysisFirst article inspection for materials with critical dimensionsMechanical testing of incoming packaging materialsDocumentation of all testing and material certificate reviewResponsible for performing In-Process and Finished Goods QC testsVisual & dimensional inspectionMechanical testing using biomechanical test equipmentScanning electron microscopyEndotoxin testingDocumentation of all testing including deviations and resultsResponsible for environmental monitoring of cleanrooms and controlled production spacesViable and non-viable air monitoringSurface microbial monitoringCharacterization of microbial strains found during routine monitoringTrack and trend all environmental monitoring dataInitiate and participate in non-conforming material and root cause investigationsInitiate and assist in ongoing production & quality process improvements and subsequent validation activitiesParticipate in non-conformance, CAPA and Customer Feedback investigations as they relate to quality controlWork with engineers, technicians, and management to identify root causes, resolve issues and suggest improvementsImplement corrective and preventive actions as required · Participate in production and quality planning meetings as neededMaintain accurate quality control records and documentationMay interact with external customer contacts such asParticipating in tours for visitors including VIPsMay be questioned and/or observed during auditsAdhere to general safety rules, manufacturing procedures, company policies and procedures, ISO and FDA regulationsWhat Makes You Stand Out Bachelor’s Degree in Biological Science, Chemistry or Medical Technology preferredMinimum (2) years working in a R&D or quality control departmentPreferred (2) years working with an electronic quality control management systemPreferred (1) year experience doing quality control in the medical device industryAbility 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 environmentHigh level of competency with Microsoft Office and database programsExcellent communication skills both written and verbalComfortable working under an ISO 13485 or 9001 Quality Management SystemComfortable working with cross functional groups with staff from all educational and professional backgroundsWorking Conditions 40 hours a week with additional hours as required by production scheduleOffice, cleanroom, and laboratory settingAbility to stand for prolonged periods of timeAbility to lift up to 75lbs

EOE/M/F/Vet/Disability