Thermo Fisher Scientific Job at Best NanoTech, Singapore

a2Q3UGVGMmx2c2ZQZDBHUkJTUTI0NkdpMXc9PQ==
  • Best NanoTech
  • Singapore

Job Description

The Senior DQA Engineer will lead all aspects of the 'end to end' design control and new product development lifecycle.


A day in the Life:


The Senior Design Quality Assurance Engineer will:

  • 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.

Job Tags

Work experience placement,

Similar Jobs

CoCreativ

Multidisciplinary Designer - Industrial Color Extended Job at CoCreativ

 ...Industrial Color is seeking a full-time multidisciplinary designer with strong beauty, skincare, or cosmetics experience to join the in-house creative team of a smaller but established beauty brand. This role is for a hands-on designer who moves confidently across print... 

bp

Federal Government Affairs Manager Job at bp

 ...Job Description: As a member of the Federal Government Affairs team you'll be a part of a dynamic organization working across regions, businesses...  ...legislative, regulatory, policy and political issues in the U.S. that could impact bp and work directly with our businesses... 

Stryker

2026 Summer Intern - Electrical Engineering - Michigan Job at Stryker

 ...important as developing life-changing medical technologies. As an intern, you wont just observe youll contribute to meaningful...  ...customer-focused attitude who bring value to their partnerships. Game changers. Persistent interns who will stop at nothing to live out... 

Boston Children's Hospital

Sterile Processing Tech III Job at Boston Children's Hospital

 ...Is knowledgeable of the roles and job responsibilities of Sterile Processing Technicians Levels I & II and may perform any of these tasks...  ...Qualifications Education: ~ High School Diploma/GED required Experience: ~ Minimum of three years of experience in Sterile... 

TradeJobsWorkforce

Police Records Specialist Job at TradeJobsWorkforce

 ...In this role, the Police Records Specialist, where you will assist with packaging, labeling, and preparing items for delivery, learn company products and services to better assist others, and help organize and maintain a tidy workspace. Additional duties include respond...