Senior Design QA Engineer

Actively Reviewing the Applications

Best NanoTech

4–8 years

Posted 3 days ago • Apply by June 11, 2026

Job Description

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 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.