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 highimpact 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 safe 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 New 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.
