Position Summary: Conducts activities within the Quality Control functions testing and release of finished product and any applicable in-Process audits (ensuring that manufacturing operations remain in control). This job serves as the lab technician in the QC group and entails ensuring availability of materials for QC testing, organization of lab processes and ensuring equipment is maintained / calibrated as appropriate, and departmental documentation is current and accurate. Responsible for ensuring deviations are properly documented, nonconforming material is segregated and secured, and the supporting of any projects assigned. Performs all duties using safety conscious practices. Individual must inspect/test/audit materials & processes in a timely fashion while, at the same time, ensuring conformance to all requirements. Primary Duties: + Perform all work in compliance with company quality procedures and standards. + Performs QC testing on finished products, prepares reports and submits for review to Quality Manager for release. + Performs a wide variety of inspection, audit and release activities. + Inherent in the process of inspection is the interpretation of requirements, and the need to use careful judgment to determine compliance. It is critical for individuals in this role to use sound judgment, and demonstrate consistent decision-making. + Performing the QC testing routinely results in the need to investigate nonconformances, and either independently address them, or interface with technicians and/or engineers to diagnose and remedy the problem. + Understands operational priorities and organizes QC activities accordingly to meet the needs. + May be responsible for the timely setup and inspection of components, raw materials, in-process, and release of finished product in accordance with specifications. Interprets blueprint requirements and confirms conformance to specifications. Leads in the standardization and advancement of inspection methods. Train new and existing QC Technicians. + Transport conforming parts to inventory, including all computer transactions and written record completion. For materials found to be nonconforming, generates “nonconforming material reports”, requiring a technically accurate description of the anomalies. + Responsible for ensuring nonconforming, Line Throw Off, and Purged material is segregated and secured including the disposition of non-conforming materials meet all necessary site and regulatory requirements. + Perform Quality Control in-process inspections & audits necessary to support Instrument Manufacturing. Assesses subassemblies, finished devices, and the assembly & test processes for conformance to documented requirements. + Responsible for ensuring that QC Inspection Methods are current and accurate. + Maintains thorough understanding of all specifications, requirements, and procedures and provides input regarding the continuous improvement of each. Failure to properly execute Quality Control inspections, tests, or analyses on the part of this position could directly result in a product recall. Operating within clearly defined guidelines, is empowered to make decisions impacting product quality, quality records, deviation resolution, and site compliance. Qualifications: + Requires a Technical degree in Biology or related field and 0-2 years of work experience in a Quality Control setting. + Degree can be either Vocational/Technical or a Bachelors + Work Experience can be accepted in lieu of a degree (3-4 years) Knowledge, Skills, and Abilities: + Hands on experience with PCR, Aseptic technique, Microbiological Media and reagent preparation, Propagation and enumeration of microbial cultures, DNA and RNA isolation, purification and quantification is preferred + Experience working in BSL2 work environment preferred + Ability to effectively communicate written and verbally. + Requires strong interpersonal skills to interacts with all levels of the organization. Also requires a strong analytical approach to decision making and problem solving. + Competence in the use of Quality Dimensional Tools and Techniques and advanced knowledge of quality systems (SAP/LIMS/Trackwise) is a plus. + Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.). + Familiarity/knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.) preferred. + Ability to work with limited supervision and to complete projects in a timely fashion. + Ability to be a representative in groups of peers from production, engineering, R&D, and quality. Working Conditions and Physical Environments: + Ability to remain in stationary position, often standing, for prolonged periods. + Ability to wear PPE correctly most of the day. + Ability to adjust or move objects up to 50 pounds in all directions. + May operate within cool temperatures and low humidity + Constant noise is common due to equipment. + Occasional environmental odors may be present. + Excellent personal hygiene and appropriate gowning required in production and laboratory areas.