About the Role In this role you will lead end-to-end design quality activities for new products ensuring they meet the highest standards of safety reliability and compliance You will work closely with cross-functional R D and engineering teams to implement robust design controls support the full product development lifecycle and help bring high impact genomic and scientific solutions to market Responsibilities Lead Design Controls activities provide guidance to Product Development Teams on Design inputs and outputs V V Risk Management Design Reviews Design Changes and Design Transfer Conduct lead support Risk analysis activities and implementation of risk controls to ensure that products are protected and effective Lead and support product development teams through processes to ensure design robustness processes include reliability statistics software and human factors Ensure product development activities are conducted in compliance with all applicable regulatory requirements international standards and internal procedures Collaborate across functions and provide oversight for the satisfactory resolution of quality and compliance issues Ensure that the product Design History File is auditable traceable and complete Serve as the Authority on the DHF for external regulatory inspections and audits Education BS degree in Engineering or in a Science field such as Chemistry Microbiology Biology or Biochemistry Experience 5 years of Quality or equivalent experience or a combination of work experience and education in a Quality Quality related field QE QA QC Supplier Quality 1 years of experience in Recent Product Introduction activities 1 years of working in the Medical Device In-Vitro Diagnostics or other regulated industry Solid understanding of product development lifecycles design change and change control risk management product and process V V methodologies Design Transfer and manufacturing production process control methodologies Experience with applicable FDA European and other relevant clinical regulatory requirements and international standards including ISO 9001 ISO 13485 ISO 14971 EU IVDR MDR 21CFR 820 Quality System Regulation etc desired ASQ certifications CQA CQE CRE Six Sigma etc desired Knowledge Skills Abilities Strong verbal and written communication skills at multiple levels in the organization Ability to work optimally within a team in a fast-paced changing environment Strong impact and influence including the ability to provide feedback to build positive relationships and improve business results Ability to travel LI-SD1