Quality Assurance/Quality Control Associate

Quality Assurance/Quality Control AssociateWe are looking for a Quality Assurance/Quality Control Associate to write or revise quality documentation, assist with raw material qualifications, perform process and final quality inspections and lab testing. You will assist in conducting product extensions. As the Quality Associate, you will be expected to work under general supervision or as part of a multifunctional team on assignments of varying degrees of complexity to ensure products and processes comply with the Company's quality system and applicable regulatory requirements.Responsibilities:Write/revise SOP's, work instructions, forms, component specifications, etc. related to QA/QC processesWrite and/or revise raw material component specificationsWrite and at times execute product extension and other various studies.Review and record test data for consistency and accuracy.Conduct laboratory testing on incoming, in process and finished materials using laboratory equipment, as required.Record and maintain temperature data for various equipment.Learn the applicable QC functions as related to the new ERP system.Interface with operations, R&D and Marcom as a team member to accomplish goals. Work as an ambassador and liaison for QA and other departments.Cross train in the value assignment process, as to data entry and review. learn the coordination with outside value assignment laboratories.Complying with cGMP and laboratory safety practicesPerform special projects as assigned by department head or other duties as assignedEmployee will contribute to a positive work environmentAssist in maintaining Quantimetrix Corporation quality systemQualifications:Bachelor of Science degree in clinical, biological, or chemical sciences2+ years' experience working in a clinical or medical device/IVD laboratory or an FDA regulated quality assurance medical device or pharmaceutical manufacturing environmentAbility to write technical reports and/or studiesAbility to analyze and present data in a coherent and scientific mannerExcellent communication skills (both verbal and written)Basic use of Excel spreadsheets and statisticsDetail orientedExperience working under FDA/ISO regulationsBest-in-Class Benefits and Perks: We value our employees' time and efforts. Our commitment to your success is enhanced by competitive compensation of $30-35/hour, depending on experience, and an extensive benefits package including:Comprehensive health coverage: Medical, dental, and vision insurance providedRobust retirement planning: 401(k) plan available with employer matchingFinancial security: Life and disability insurance for added protectionFlexible financial options: Health savings and flexible spending accounts offeredWell-being and work-life balance: Paid time off, flexible schedule, and remote work choices providedPlus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.Join us on the journey of excellence and innovation. Apply now and be a part of something extraordinary! Ready to take the lead in our manufacturing revolution? If you're excited to drive change, inspire a team, and make a lasting impact, we want to hear from you!We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.

Created: 2025-01-14